67. Polycystic kidney disease Clinical trials / Disease details
Clinical trials : 216 / Drugs : 219 - (DrugBank : 50) / Drug target genes : 39 - Drug target pathways : 151
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04939935 (ClinicalTrials.gov) | April 2022 | 16/6/2021 | Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD) | Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD): A Randomised Placebo-Controlled Trial | Autosomal Dominant Polycystic Kidney Disease | Drug: Metformin XR;Other: Control | The University of Queensland | NULL | Not yet recruiting | 18 Years | 70 Years | All | 1164 | Phase 3 | Australia |
| 2 | EUCTR2021-003062-12-SK (EUCTR) | 11/03/2022 | 16/11/2021 | A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment. | A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Lixivaptan Product Code: 0C23 INN or Proposed INN: Lixivaptan Other descriptive name: Lixivaptan | Palladio Biosciences Inc. | ,NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Portugal;Belarus;Serbia;United States;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Australia;Denmark;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand | ||
| 3 | NCT05190744 (ClinicalTrials.gov) | March 1, 2022 | 29/12/2021 | PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration | A Multi-center, Open-Label, Exploratory Study to Assess the Efficacy of PB in Decreasing the Urine Output and Increasing the Urine Osmolality in Patients With Hereditary Nephrogenic Diabetes Insipidus, Patients With Autosomal Dominant Polycystic Kidney Disease Treated With Tolvaptan, And Severely Polyuric Patients With Previous Lithium Administration (Serendipity-PB1) | Autosomal Dominant Polycystic Kidney Disease;Nephrogenic Diabetes Insipidus;Acquired Nephrogenic Diabetes Insipidus;Congenital Nephrogenic Diabetes Insipidus | Drug: PB | Mayo Clinic | Hopital du Sacre-Coeur de Montreal | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 4 | NCT05208866 (ClinicalTrials.gov) | February 10, 2022 | 7/1/2022 | Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303 | PA-ADPKD-304: A Phase 3, Open-label, Roll-over Study to Assess Long-term Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Who Completed Study PA-ADPKD-303: The ALERT Study | Polycystic Kidney Disease, Adult | Drug: Lixivaptan | Palladio Biosciences | NULL | Enrolling by invitation | 18 Years | N/A | All | 12 | Phase 3 | United States |
| 5 | EUCTR2021-003062-12-BG (EUCTR) | 09/02/2022 | 06/12/2021 | A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment. | A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Lixivaptan Product Code: 0C23 INN or Proposed INN: Lixivaptan Other descriptive name: Lixivaptan | Palladio Biosciences Inc. | ,NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Israel;Chile;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia | ||
| 6 | EUCTR2021-003062-12-ES (EUCTR) | 21/01/2022 | 20/10/2021 | A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment. | A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Lixivaptan Product Code: 0C23 INN or Proposed INN: Lixivaptan Other descriptive name: Lixivaptan | Palladio Biosciences Inc. | ,NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia | ||
| 7 | EUCTR2021-003062-12-IT (EUCTR) | 20/01/2022 | 18/10/2021 | A clinical trial to look at how safe and how effective Lixivaptan in patients with kidney disease compared to a placebo treatment. | A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Lixivaptan Product Code: [0C23] INN or Proposed INN: Lixivaptan | Palladio Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia | ||
| 8 | EUCTR2021-002551-11-DK (EUCTR) | 18/01/2022 | 27/05/2021 | Chronic kidney disease – imaging the metabolic derangements with ultra-sensitive MRI | Chronic kidney disease – imaging the metabolic derangements with ultra-sensitive MRI | Chronic kidney disease and polycystic kidney disease MedDRA version: 23.1;Level: PT;Classification code 10064848;Term: Chronic kidney disease;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] | Product Name: Hyperpolarized [1-13C]pyruvate INN or Proposed INN: SODIUM PYRUVATE Other descriptive name: SODIUM PYRUVATE | Aarhus University | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Denmark | ||
| 9 | EUCTR2021-003062-12-HU (EUCTR) | 03/01/2022 | 05/11/2021 | A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment. | A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Lixivaptan Product Code: 0C23 INN or Proposed INN: Lixivaptan Other descriptive name: Lixivaptan | Palladio Biosciences Inc. | ,NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia | ||
| 10 | EUCTR2020-000433-40-NL (EUCTR) | 30/12/2021 | 03/08/2021 | Treatment of stiffness in blood vessels in patients with familial cystic kidney disease | Treatment of vascular stiffness in patients with autosomal dominant polycystic kidney disease - TRAMPOLINE | Autosomal dominant polycystic kidney disease;Therapeutic area: Not possible to specify | Trade Name: Amiloride Product Name: Amiloride INN or Proposed INN: AMILORIDE Trade Name: Sodium Chloride INN or Proposed INN: Sodium chloride Other descriptive name: Sodium Chloride | Erasmus University Medical Centre Rotterdam | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 4 | Netherlands | ||
| 11 | NCT04064346 (ClinicalTrials.gov) | October 28, 2021 | 19/8/2019 | Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease | A 2-Year, Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-label Phase | Polycystic Kidney Disease, Adult | Drug: Lixivaptan;Drug: Placebo | Palladio Biosciences | NULL | Recruiting | 18 Years | 60 Years | All | 1200 | Phase 3 | United States;Argentina;Australia;Canada;Chile;Hungary;Israel;Romania;Spain |
| 12 | EUCTR2020-005949-16-NL (EUCTR) | 25/10/2021 | 21/10/2021 | A study into the efficacy and toleratability of leuprorelin by patients suffering from severe polycystic liver disease | A GnRH Agonist IN pre-menopausal women STudy to treat severe Polycystic Liver Disease - AGAINST-PLD | Severe polycystic liver disease in female patients MedDRA version: 20.1;Level: PT;Classification code 10048834;Term: Polycystic liver disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Level: LLT;Classification code 10036045;Term: Polycystic kidney;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 23.0;Classification code 10083939;Term: Autosomal dominant polycystic liver disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Lucrin Product Name: Lucrin | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 36 | Phase 2 | Netherlands | ||
| 13 | NCT04908462 (ClinicalTrials.gov) | June 8, 2021 | 18/5/2021 | To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease Subjects | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease Subjects Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 | Autosomal Dominant Polycystic Kidney | Drug: AL01211 or Placebo (Part A);Drug: AL01211 or Placebo (Part B);Drug: AL01211 or Placebo (Part C) | AceLink Therapeutics, Inc. | Novotech (Australia) Pty Limited | Recruiting | 18 Years | 55 Years | All | 98 | Phase 1 | Australia |
| 14 | EUCTR2020-004400-34-NL (EUCTR) | 12/05/2021 | 04/02/2021 | Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustat | Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT | Congenital cystic kidney disease MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: GZ/SAR402671 | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 640 | Phase 3 | Portugal;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of | ||
| 15 | EUCTR2020-004400-34-BE (EUCTR) | 11/05/2021 | 18/02/2021 | Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustat | Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT | Congenital cystic kidney disease MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: GZ/SAR402671 | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 640 | Phase 3 | Portugal;Czechia;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of | ||
| 16 | EUCTR2020-004400-34-PT (EUCTR) | 30/04/2021 | 05/03/2021 | Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustat | Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT | Congenital cystic kidney disease MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: GZ/SAR402671 | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 640 | Phase 3 | Portugal;Czechia;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of | ||
| 17 | EUCTR2020-004400-34-IT (EUCTR) | 14/04/2021 | 08/06/2021 | Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustat | Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT | Congenital cystic kidney disease MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Venglustat Product Code: [SAR402671, GZ402671 o GZ/SAR402671] INN or Proposed INN: venglustat malato Other descriptive name: GZ/SAR402671 | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Not Recruiting | Female: yes Male: yes | 640 | Phase 3 | Portugal;Czechia;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of | ||
| 18 | NCT04786574 (ClinicalTrials.gov) | April 1, 2021 | 19/2/2021 | A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) | A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 12 Weeks of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Drug: Tolvaptan (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not yet recruiting | N/A | 12 Weeks | All | 20 | Phase 3 | NULL |
| 19 | NCT04782258 (ClinicalTrials.gov) | April 1, 2021 | 19/2/2021 | A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) | A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Autosomal Recessive Polycystic Kidney (ARPKD) | Drug: Tolvaptan Suspension;Drug: Tolvaptan Tablets | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not yet recruiting | N/A | 18 Years | All | 20 | Phase 3 | NULL |
| 20 | EUCTR2020-004400-34-DE (EUCTR) | 23/03/2021 | 25/02/2021 | Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustat | Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT | Congenital cystic kidney disease MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: GZ/SAR402671 | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 640 | Phase 3 | Portugal;Czechia;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Korea, Republic of | ||
| 21 | NCT04705051 (ClinicalTrials.gov) | February 9, 2021 | 8/1/2021 | Multicenter, Open-label, Extension Study to Characterize the Long-term Efficacy and Safety of Early Versus Delayed Treatment With Venglustat (GZ/SAR402671) in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Multicenter, Open-label, Extension Study to Characterize the Long-term Efficacy and Safety of Early Versus Delayed Treatment With Venglustat (GZ/SAR402671) in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Congenital Cystic Kidney Disease | Drug: Venglustat GZ402671 | Sanofi | NULL | Terminated | 18 Years | N/A | All | 24 | Phase 3 | United States;Australia;Belgium;France;Germany;Japan;Korea, Republic of;Netherlands;Romania;Spain |
| 22 | JPRN-jRCT2031200348 | 09/02/2021 | 05/02/2021 | Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustat | Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT | Congenital cystic kidney disease | Drug: Venglustat (GZ402671) Pharmaceutical form: capsule, Route of administration: oral | Tanaka Tomoyuki | NULL | Suspended | >= 18age old | Not applicable | Both | 640 | Phase 3 | United States;Japan |
| 23 | NCT04680780 (ClinicalTrials.gov) | January 10, 2021 | 1/10/2020 | Ketogenic Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Ketogenic Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | ADPKD | Other: Ketogenic diet;Other: 3-days water-fasting;Other: Control | University of Cologne | NULL | Active, not recruiting | 18 Years | 60 Years | All | 63 | N/A | Germany |
| 24 | NCT04578548 (ClinicalTrials.gov) | November 10, 2020 | 1/10/2020 | A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | An Exploratory, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Orally Administered GLPG2737 for 52 Weeks, Followed by an Open-label Extension Period of 52 Weeks in Subjects With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: Placebo;Drug: GLPG2737 | Galapagos NV | NULL | Active, not recruiting | 18 Years | 50 Years | All | 66 | Phase 2 | Spain;Poland;Netherlands;Italy;Germany;Czechia;Belgium |
| 25 | NCT04407481 (ClinicalTrials.gov) | November 1, 2020 | 19/5/2020 | PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN) | PENGUIN: PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD | Polycystic Kidney Disease, Adult;Polycystic Kidney, Autosomal Dominant | Drug: Aminohippurate Sodium Inj 20%;Drug: Iohexol Inj 300 milligrams per milliliter (MG/ML);Radiation: PET/CT Scan | University of Colorado Denver School of Medicine Barbara Davis Center | NULL | Recruiting | 18 Years | 40 Years | All | 20 | United States | |
| 26 | EUCTR2019-003521-21-CZ (EUCTR) | 14/10/2020 | 28/07/2020 | A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney disease | An exploratory, randomized, double-blind, placebo-controlled, multicenterstudy to evaluate the efficacy, safety, tolerability and pharmacokinetics oforally administered GLPG2737 for 52 weeks, followed by an open-labelextension period of 52 weeks in subjects with autosomal dominantpolycystic kidney disease | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Spain;Belgium;Germany;Netherlands;Italy | ||
| 27 | NCT04536688 (ClinicalTrials.gov) | October 13, 2020 | 24/8/2020 | A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney Disease | A Phase 1b, Multicenter, Open-Label, Adaptive Design Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RGLS4326 Administered Via SC Injection to Patients With Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney Disease, Autosomal Dominant | Drug: RGLS4326 | Regulus Therapeutics Inc. | NULL | Completed | 18 Years | 70 Years | All | 19 | Phase 1 | United States |
| 28 | EUCTR2019-003521-21-DE (EUCTR) | 14/09/2020 | 10/03/2020 | A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney disease | An exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Spain;Belgium;Netherlands;Germany;Italy | ||
| 29 | NCT04310319 (ClinicalTrials.gov) | September 7, 2020 | 3/3/2020 | Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt | Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt | Polycystic Kidney, Autosomal Dominant;ADPKD;Autosomal Dominant Polycystic Kidney | Dietary Supplement: Sodiumchloride;Dietary Supplement: Protein;Dietary Supplement: Placebo comparator (salt);Dietary Supplement: Placebo comparator (protein) | Esther Meijer | NULL | Recruiting | 18 Years | N/A | All | 12 | N/A | Netherlands |
| 30 | NCT04152837 (ClinicalTrials.gov) | September 2, 2020 | 31/10/2019 | Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease | An Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT Study | Polycystic Kidney Disease, Adult | Drug: Lixivaptan | Palladio Biosciences | NULL | Recruiting | 18 Years | 65 Years | All | 50 | Phase 3 | United States |
| 31 | EUCTR2019-003521-21-IT (EUCTR) | 22/07/2020 | 11/01/2021 | A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney disease | An exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, in subjects with autosomal dominant polycystic kidney disease - A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney di | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: GLPG2737 Product Code: [G1117337] Other descriptive name: GLPG2737 | GALAPAGOS NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Italy;United Kingdom;Germany;Netherlands;Bulgaria;Ireland;Belgium;Greece;Czech Republic | ||
| 32 | EUCTR2019-003521-21-NL (EUCTR) | 18/03/2020 | 07/11/2019 | A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney disease | An exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Spain;Belgium;Germany;Netherlands;Italy | ||
| 33 | EUCTR2018-004651-20-GB (EUCTR) | 13/02/2020 | 07/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;France;Czech Republic;Spain;Belgium;Australia;Germany;Italy;United Kingdom | ||
| 34 | EUCTR2019-003521-21-BE (EUCTR) | 20/01/2020 | 24/10/2019 | A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney disease | An exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Spain;Belgium;Germany;Netherlands;Italy | ||
| 35 | EUCTR2018-004651-20-DE (EUCTR) | 20/01/2020 | 07/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 850 | Phase 3 | France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy;Japan | ||
| 36 | EUCTR2018-004651-20-CZ (EUCTR) | 12/12/2019 | 23/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy;Japan | ||
| 37 | EUCTR2018-004651-20-IT (EUCTR) | 20/11/2019 | 05/01/2021 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone methyl 5 mg Product Code: [RTA 402] INN or Proposed INN: Bardoxolone Metile Other descriptive name: Bardoxolone methyl Product Name: Bardoxolone methyl 10 mg Product Code: [RTA 402] INN or Proposed INN: bardoxolone methyl Other descriptive name: bardoxolone methyl Product Name: Bardoxolone methyl 20 mg Product Code: [RTA 402] INN or Proposed INN: Bardoxolone methyl Other descriptive name: Bardoxolone methyl Product Name: Bardoxolone methyl 15 mg Product Code: [RTA 402] INN or Proposed INN: Bardoxolone Methyl Other descriptive name: Bardoxolone methyl | REATA PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy | ||
| 38 | EUCTR2018-004651-20-ES (EUCTR) | 19/11/2019 | 04/09/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Belgium;Spain;Australia;Germany;Italy;United Kingdom | ||
| 39 | EUCTR2018-004651-20-BE (EUCTR) | 14/10/2019 | 29/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Japan;Italy | ||
| 40 | NCT03949894 (ClinicalTrials.gov) | July 1, 2019 | 16/4/2019 | Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease | Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Tolvaptan | Korea Otsuka Pharmaceutical Co., Ltd. | NULL | Active, not recruiting | 19 Years | 50 Years | All | 118 | Phase 4 | Korea, Republic of |
| 41 | NCT03918447 (ClinicalTrials.gov) | May 29, 2019 | 12/4/2019 | A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON | A Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney;ADPKD | Drug: Bardoxolone methyl oral capsule;Drug: Placebo oral capsule | Reata Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | 70 Years | All | 550 | Phase 3 | United States;Australia;Belgium;Czechia;France;Germany;Italy;Japan;Spain;United Kingdom |
| 42 | EUCTR2017-004084-12-AT (EUCTR) | 11/04/2019 | 14/01/2019 | A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD Patients | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 982 | Phase 2 | United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 43 | JPRN-jRCTs031180259 | 01/04/2019 | 14/03/2019 | Tolvaptan Intervention study and Genetic mutation of AutosomalDominant Polycystic Kidney Disease | Tolvaptan Intervention study to Autosomal Dominant PolycysticKidney Disease patients without Genetic mutation of disease gene - TIAG | ADPKD | Tolvaptan treatment | Horie Shigeo | NULL | Complete | >= 20age old | Not applicable | Both | 10 | N/A | Japan |
| 44 | JPRN-UMIN000039943 | 2019/03/08 | 25/03/2020 | An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease | An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease - A Trial of Bardoxolone Methyl in Patients with Chronic Kidney Disease - EAGLE | Chronic Kidney DiseaseAlport SyndromeAutosomal Dominant Polycystic Kidney | Bardoxolone methyl | Reata Pharmaceuticals, Inc. | Kyowa Kirin Co., Ltd. | Recruiting | Not applicable | Not applicable | Male and Female | 480 | Phase 3 | Japan,North America,Australia,Europe |
| 45 | NCT03749447 (ClinicalTrials.gov) | March 8, 2019 | 19/11/2018 | An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) | An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease | Chronic Kidney Diseases;Alport Syndrome;Autosomal Dominant Polycystic Kidney | Drug: Bardoxolone methyl | Reata Pharmaceuticals, Inc. | NULL | Recruiting | 12 Years | N/A | All | 480 | Phase 3 | United States;Puerto Rico;Japan;Australia |
| 46 | NCT03717181 (ClinicalTrials.gov) | February 19, 2019 | 22/10/2018 | Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney Disease | Expanded Access Use of Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney Disease | Polycystic Kidney | Drug: Lixivaptan | Palladio Biosciences | NULL | No longer available | 15 Years | 60 Years | All | United States | ||
| 47 | EUCTR2017-004084-12-NL (EUCTR) | 13/02/2019 | 06/06/2018 | A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD Patients | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 982 | Phase 2 | United States;Portugal;Czechia;Taiwan;Spain;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 48 | JPRN-JapicCTI-184192 | 31/1/2019 | 05/11/2018 | A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD Patients. | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Polycystic kidney, autosomal dominant | Intervention name : GZ402671 INN of the intervention : venglustat Dosage And administration of the intervention : once daily for 24 months Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : once daily for 24 months | Sanofi K.K. | NULL | other | 18 | 55 | BOTH | 640 | Phase 2-3 | Japan, Asia except Japan, North America, South America, Europe, Oceania |
| 49 | NCT04284657 (ClinicalTrials.gov) | January 30, 2019 | 11/4/2019 | Pravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease | Pravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: Pravastatin;Drug: sodium citrate | University of Southern California | NULL | Enrolling by invitation | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 50 | NCT03764605 (ClinicalTrials.gov) | January 30, 2019 | 29/11/2018 | Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease | Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease. A Phase 3a, Indipendent, Multicentre, Two Parallel Arms, Randomized Controlled Trial | ADPKD | Drug: Metformin;Drug: Tolvaptan | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | NULL | Not yet recruiting | 18 Years | 50 Years | All | 150 | Phase 3 | Italy |
| 51 | EUCTR2017-004084-12-GB (EUCTR) | 28/01/2019 | 24/05/2018 | A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD Patients | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 982 | Phase 2 | United States;Portugal;Czechia;Taiwan;Spain;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 52 | NCT03541447 (ClinicalTrials.gov) | December 12, 2018 | 17/5/2018 | Tolvaptan-Octreotide LAR Combination in ADPKD | A Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or Hyperfiltration | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan;Drug: Octreotide LAR;Other: Placebo | Mario Negri Institute for Pharmacological Research | Otsuka Pharmaceutical Italy S.r.l. | Completed | 18 Years | N/A | All | 20 | Phase 2 | Italy |
| 53 | EUCTR2018-000477-77-IT (EUCTR) | 08/11/2018 | 04/11/2020 | Evaluation of Metformin and Tolvaptan in slowing disease progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Metformin versus Tolvaptan in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD): a phase 3a, independent, multi-centre, 2 parallel arms randomized controlled trial - METROPOLIS | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: ZUGLIMET - 500 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER PVC/AL Product Name: METFORMINA Product Code: [METFORMINA] INN or Proposed INN: METFORMINA Other descriptive name: METFORMIN Trade Name: JINARC - 15 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE Product Name: TOLVAPTAN 15 Product Code: [TOLVAPTAN 15] INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 30 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE Product Name: TOLVAPTAN 30 Product Code: [TOLVAPTAN 30] INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG) Product Name: TOLVAPTAN 45/15 Product Code: [TOLVAPTAN 45/15] INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG) Product Name: TOLVAPTAN 60/30 Product Code: [TOL | U.O. NEFROLOGIA, DIALISI E TRAPIANTO AZIENDA OSPEDALIERO UNIVERSITARIA POLICLINICO DI BARI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Italy | ||
| 54 | EUCTR2017-004084-12-DK (EUCTR) | 07/11/2018 | 23/05/2018 | A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD Patients | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 982 | Phase 2 | Portugal;United States;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 55 | NCT03687554 (ClinicalTrials.gov) | October 5, 2018 | 26/9/2018 | Effect of Venglustat in Patients With Renal Impairment | A Phase I, Single-Center, Open-label, Single Dose Pharmacokinetic and Tolerability Study of GZ402671 in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function | Healthy Volunteers;Polycystic Kidney, Autosomal Dominant | Drug: Venglustat GZ/SAR402671 | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 79 Years | All | 24 | Phase 1 | United States |
| 56 | NCT03523728 (ClinicalTrials.gov) | October 4, 2018 | 1/5/2018 | A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Polycystic Kidney, Autosomal Dominant | Drug: Venglustat GZ402671;Drug: Placebo | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | 55 Years | All | 478 | Phase 2/Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Germany;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Spain;Taiwan;Turkey;United Kingdom |
| 57 | NCT03487913 (ClinicalTrials.gov) | September 14, 2018 | 16/3/2018 | The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease | A Phase 2, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: Lixivaptan | Palladio Biosciences | NULL | Completed | 18 Years | 65 Years | All | 31 | Phase 2 | United States |
| 58 | NCT03596957 (ClinicalTrials.gov) | September 12, 2018 | 14/2/2018 | Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease | Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney | Drug: Tolvaptan | Lisbet Brandi | NULL | Unknown status | 18 Years | 65 Years | All | 90 | Phase 4 | Denmark |
| 59 | EUCTR2017-004084-12-BE (EUCTR) | 31/08/2018 | 31/05/2018 | A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD Patients | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 982 | Phase 2 | United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 60 | EUCTR2017-004084-12-PT (EUCTR) | 06/08/2018 | 11/06/2018 | A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD Patients | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 982 | Phase 2 | Portugal;United States;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 61 | EUCTR2017-004701-40-IT (EUCTR) | 06/08/2018 | 26/09/2019 | STUDY TO ASSESS THE SHORT-TERM EFFECT OF THE ADMINISTRATION OF TOLVAPTAN AND OCTREOTIDE LAR COMPARED TO THE COMBINATION OF TOLVAPTAN AND PLACEBO IN PATIENTS AFFECTED BY ADPKD WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION | A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE LAR COMBINATION THERAPY IN ADPKD PATIENTS WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION - Tolvaptan-Octreotide combination in ADPKD | Autosomal Dominant Policiytic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG) Product Name: Jinarc INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG) Product Name: Jinarc INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 30 MG +90 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 90 MG) Product Name: Jinarc INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: SANDOSTATINA - LAR 20 MG/2.5 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE FLACONE POLVERE + SIRINGA PRERIEMPITA 2.5 ML + 2 AGHI Product Name: sandostatina LAR Product Code: sandostatina | IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Italy | ||
| 62 | EUCTR2017-004084-12-IT (EUCTR) | 12/07/2018 | 17/06/2021 | Study of Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - SAVE-PKD | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU | GENZYME CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 982 | Phase 2 | Portugal;United States;Czechia;Taiwan;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 63 | EUCTR2017-004084-12-DE (EUCTR) | 10/07/2018 | 22/05/2018 | A Medical Research Study Designed to Determine if Venglustat can be aFuture Treatment for ADPKD Patients | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 982 | Phase 2 | United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 64 | EUCTR2017-004084-12-CZ (EUCTR) | 03/07/2018 | 13/06/2018 | A Medical Research Study Designed to Determine if Venglustat can be a Future Treatment for ADPKD Patients | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 982 | Phase 2 | United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 65 | EUCTR2017-004084-12-ES (EUCTR) | 05/06/2018 | 06/06/2018 | Study of Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - SAVE-PKD | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: Venglustat Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 836 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Spain;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 66 | EUCTR2017-003864-10-NL (EUCTR) | 02/05/2018 | 08/03/2018 | Medication for excessive urine production in patients treated with tolvaptan | Hydrochlorothiazide and metformin cross-over study for attenuating aquaretic side-effects in ADPKD patients treated with tolvaptan | Autosomal dominant polycystic kidney disease;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Hydrochlorothiazide Product Code: HCT Product Name: Metformin | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Netherlands | ||
| 67 | NCT03423810 (ClinicalTrials.gov) | April 23, 2018 | 31/1/2018 | Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients | Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients | Polycystic Kidney Diseases | Drug: Hydralazine | University of Kansas Medical Center | NULL | Completed | 18 Years | 65 Years | All | 14 | Early Phase 1 | United States |
| 68 | EUCTR2017-004115-39-DK (EUCTR) | 08/02/2018 | 13/12/2017 | Same as above | Subacute Effect of Tolvaptan on Total Kidney Volumen in Adult Patients with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney DIsease MedDRA version: 20.0;Level: LLT;Classification code 10036045;Term: Polycystic kidney;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Jinarc 15 mg tablets, Jinarc 45 mg tablets Product Name: Jinarc - Tolvaptan tablets Product Code: 15 or 45 mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN Trade Name: Jinarc 30 mg tablets, Jinarc 60 mg tablets Product Name: Jinarc - Tolvaptan tablets Product Code: 30 or 60 mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN Trade Name: Jinarc 30 mg tablets, 90 mg tablets Product Name: Jinarc - Tolvaptan tablets Product Code: 30 or 90 mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN | Nordsjællands Hospital, Department of Cardiology, Nephrology and Endocrinology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 4 | Denmark | ||
| 69 | NCT03366337 (ClinicalTrials.gov) | December 26, 2017 | 4/12/2017 | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases | IgA Nephropathy;CKD Associated With Type 1 Diabetes;Focal Segmental Glomerulosclerosis;Autosomal Dominant Polycystic Kidney | Drug: Bardoxolone methyl capsules | Reata Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 65 Years | All | 103 | Phase 2 | United States |
| 70 | NCT03273413 (ClinicalTrials.gov) | August 31, 2017 | 1/9/2017 | Statin Therapy in Patients With Early Stage ADPKD | Statin Therapy in Patients With Early Stage ADPKD | ADPKD;Autosomal Dominant Polycystic Kidney | Drug: Pravastatin;Drug: Placebo | University of Colorado, Denver | NULL | Recruiting | 25 Years | 60 Years | All | 200 | Phase 4 | United States |
| 71 | NCT03203642 (ClinicalTrials.gov) | August 9, 2017 | 26/6/2017 | Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD | A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney;ADPKD | Drug: Tesevatinib;Drug: Placebo | Kadmon Corporation, LLC | NULL | Completed | 18 Years | 60 Years | All | 80 | Phase 2 | United States |
| 72 | NCT03096080 (ClinicalTrials.gov) | June 14, 2017 | 6/3/2017 | A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD) | A Phase 1, Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Polycystic Kidney, Autosomal Recessive | Drug: Tesevatinib | Kadmon Corporation, LLC | NULL | Completed | 5 Years | 12 Years | All | 10 | Phase 1 | United States |
| 73 | NCT03102632 (ClinicalTrials.gov) | June 1, 2017 | 27/3/2017 | A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease | A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney | Other: High Water Intake | The Rogosin Institute | Weill Medical College of Cornell University | Active, not recruiting | 18 Years | 65 Years | All | 10 | N/A | United States |
| 74 | NCT02903511 (ClinicalTrials.gov) | November 2016 | 13/9/2016 | Feasibility Study of Metformin Therapy in ADPKD | Feasibility Study of Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease. | Polycystic Kidney, Autosomal Dominant | Drug: Metformin;Drug: Placebo | University of Colorado, Denver | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 30 Years | 60 Years | All | 56 | Phase 2 | United States |
| 75 | EUCTR2016-000187-42-GB (EUCTR) | 24/10/2016 | 06/05/2016 | A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Tolvaptan 7.5 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 15mg Tablet Product Name: Tolvaptan 15 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 30 Tablet Product Name: Tolvaptan 30 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | Belgium;Germany;Italy;United Kingdom | ||
| 76 | EUCTR2016-000187-42-DE (EUCTR) | 13/10/2016 | 10/05/2016 | A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Tolvaptan 7.5 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 15mg Tablet Product Name: Tolvaptan 15 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 30 Tablet Product Name: Tolvaptan 30 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Belgium;Germany;United Kingdom;Italy | ||
| 77 | NCT02729662 (ClinicalTrials.gov) | October 1, 2016 | 11/3/2016 | Efficacy of Tolvaptan on ADPKD Patients | Longitudinal Efficacy and Safety Study of Tolvaptan on Autosomal Dominant Polycystic Kidney Disease Patients (LET-PKD Study) | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan | Kyorin University | NULL | Active, not recruiting | 18 Years | N/A | All | 118 | N/A | Japan |
| 78 | EUCTR2016-000187-42-IT (EUCTR) | 26/09/2016 | 12/05/2016 | A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Tolvaptan 7.5 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 15mg Tablet Product Name: Tolvaptan 15 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 30 Tablet Product Name: Tolvaptan 30 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Hungary;Poland;Belgium;Spain;Germany;United Kingdom;Italy | ||
| 79 | NCT02933268 (ClinicalTrials.gov) | September 26, 2016 | 18/9/2016 | High Water Intake in Polycystic Kidney Disease | Determining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility Trial | Autosomal Dominant Polycystic Kidney Disease | Dietary Supplement: High water intake;Other: Ad libitum water intake | Cambridge University Hospitals NHS Foundation Trust | PKD Charity;Addenbrookes Charitable Trust;British Renal Society & British Kidney Patient Association | Completed | 16 Years | N/A | All | 42 | N/A | United Kingdom |
| 80 | NCT02964273 (ClinicalTrials.gov) | September 2016 | 15/9/2016 | Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan Followed by a Two Year Open-label Extension in Children and Adolescent Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Phase A Tolvaptan;Drug: Placebo Phase A;Drug: Phase B Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 4 Years | 17 Years | All | 91 | Phase 3 | Belgium;Germany;Italy;United Kingdom |
| 81 | EUCTR2016-000187-42-BE (EUCTR) | 24/08/2016 | 24/05/2016 | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Tolvaptan 7.5 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 15mg Tablet Product Name: Tolvaptan 15 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 30 Tablet Product Name: Tolvaptan 30 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Belgium;Germany;United Kingdom;Italy | ||
| 82 | NCT03406286 (ClinicalTrials.gov) | July 19, 2016 | 22/12/2017 | Samsca PMS in ADPKD Patients | Post-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKD | Safety | Drug: Tolvaptan | Korea Otsuka Pharmaceutical Co., Ltd. | NULL | Recruiting | 18 Years | N/A | All | 600 | Korea, Republic of | |
| 83 | NCT02656017 (ClinicalTrials.gov) | June 27, 2016 | 23/12/2015 | Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease | Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney, Autosomal Dominant | Drug: Metformin;Other: Placebo | Kyongtae Ty Bae, M.D., Ph.D. | Tufts Medical Center;University of Maryland, Baltimore;University of Southern California;United States Department of Defense | Completed | 18 Years | 60 Years | All | 97 | Phase 2 | United States |
| 84 | EUCTR2014-001516-19-DK (EUCTR) | 15/06/2016 | 14/04/2016 | This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Australia;South Africa;Norway;Netherlands;Germany;Sweden | ||
| 85 | EUCTR2014-001516-19-HU (EUCTR) | 02/05/2016 | 01/03/2016 | This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Australia;South Africa;Norway;Netherlands;Germany;Sweden | ||
| 86 | EUCTR2014-001516-19-CZ (EUCTR) | 06/04/2016 | 28/01/2016 | This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;South Africa;Norway;Germany;Netherlands;Sweden | ||
| 87 | EUCTR2014-001516-19-SE (EUCTR) | 04/02/2016 | 05/11/2014 | This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;South Africa;Norway;Netherlands;Germany;Sweden | ||
| 88 | NCT02697617 (ClinicalTrials.gov) | January 26, 2016 | 30/10/2015 | Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease | Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney | Polycystic Kidney Disease | Drug: Pioglitazone;Drug: Placebo | Indiana University | NULL | Active, not recruiting | 18 Years | 55 Years | All | 18 | Phase 2 | United States |
| 89 | EUCTR2014-001501-41-BE (EUCTR) | 16/01/2016 | 17/12/2015 | A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD), Patients with Increased Risk of Liver Injury;Therapeutic area: Not possible to specify | Trade Name: Jinarc INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | France;United States;Argentina;Belgium;Germany;Japan | ||
| 90 | EUCTR2014-001501-41-FR (EUCTR) | 30/12/2015 | 15/01/2016 | A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD), Patients with Increased Risk of Liver Injury;Therapeutic area: Not possible to specify | Trade Name: Jinarc INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;France;Argentina;Belgium;Germany;Japan | ||
| 91 | NCT03803124 (ClinicalTrials.gov) | December 2015 | 7/1/2019 | Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD | Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD | Polycystic Kidney, Autosomal Dominant | Drug: Tolvaptan;Drug: Placebo | Regional Hospital Holstebro | NULL | Completed | 18 Years | N/A | All | 20 | Phase 3 | Denmark |
| 92 | NCT02616055 (ClinicalTrials.gov) | December 2015 | 24/11/2015 | Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 | Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 in Subjects With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: tesevatinib | Kadmon Corporation, LLC | NULL | Terminated | 18 Years | 55 Years | All | 15 | Phase 2 | United States |
| 93 | NCT02494141 (ClinicalTrials.gov) | November 12, 2015 | 25/6/2015 | Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD | Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD | Polycystic Kidney, Autosomal Dominant | Drug: Curcumin;Other: Placebo | University of Colorado, Denver | NULL | Completed | 6 Years | 25 Years | All | 68 | Phase 4 | United States |
| 94 | EUCTR2014-001516-19-ES (EUCTR) | 30/10/2015 | 11/09/2015 | This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Australia;Peru;South Africa;Netherlands;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | ||
| 95 | EUCTR2014-000226-38-FR (EUCTR) | 16/10/2015 | 11/12/2015 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Spain;Taiwan;United States | ||
| 96 | NCT02558595 (ClinicalTrials.gov) | September 22, 2015 | 21/9/2015 | Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2) | Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney Disease | Polycystic Kidney Disease | Dietary Supplement: Niacinamide;Other: Placebo | University of Kansas Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | 60 Years | All | 36 | Phase 2 | United States |
| 97 | NCT02776241 (ClinicalTrials.gov) | September 2015 | 4/5/2016 | Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney Disease | Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA Study | ADPKD | Other: water | Rigshospitalet, Denmark | Aarhus University Hospital | Completed | 18 Years | N/A | All | 40 | N/A | Denmark |
| 98 | EUCTR2015-001903-30-DK (EUCTR) | 26/06/2015 | 13/05/2015 | Effect of tolvaptan on renal blood flow and glomerular filtration in patients with polycystic kidney disease | Effect of tolvaptan on RBF and GFR in ADPKD - Tolvaptan and RPF in ADPKD | Adult dominant polycystic kidney disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Physical Phenomena [G01] | Trade Name: Samsca INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN | Department of Medical Research | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Denmark | ||
| 99 | EUCTR2014-001516-19-PL (EUCTR) | 27/05/2015 | 19/02/2015 | This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Australia;South Africa;Norway;Netherlands;Germany;Sweden | ||
| 100 | EUCTR2014-001516-19-FR (EUCTR) | 30/03/2015 | 07/01/2015 | This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;South Africa;Netherlands;United Kingdom;Czech Republic;Hungary;Mexico;Sweden;Norway;Germany;Romania;Poland;Belgium;Brazil;Argentina;Canada | ||
| 101 | EUCTR2014-001516-19-GB (EUCTR) | 26/03/2015 | 30/09/2014 | This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease - Otsuka_156-13-211 | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;South Africa;Netherlands;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | ||
| 102 | EUCTR2014-000226-38-PL (EUCTR) | 10/03/2015 | 08/12/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Norway;Germany;Sweden | ||
| 103 | EUCTR2014-001516-19-NL (EUCTR) | 09/03/2015 | 06/11/2014 | This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Germany;Norway;Sweden;Romania;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Netherlands;South Africa;Peru;Denmark;Australia;France;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Spain;United States | ||
| 104 | EUCTR2014-001516-19-BE (EUCTR) | 11/02/2015 | 17/11/2014 | This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;South Africa;Netherlands;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | ||
| 105 | NCT02527863 (ClinicalTrials.gov) | February 2015 | 18/2/2015 | Effect of the Aquaretic Tolvaptan on Nitric Oxide System | The Effects of Tolvaptan on Renal Handling of Water and Sodium, Vasoactive Hormones and Central Hemodynamics During Baseline Conditions and After Inhibition of the Nitric Oxide System in Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan;Drug: Placebo | Regional Hospital Holstebro | Aarhus University Hospital | Completed | 18 Years | 65 Years | All | 18 | Phase 2 | Denmark |
| 106 | EUCTR2014-000226-38-CZ (EUCTR) | 21/01/2015 | 13/11/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 107 | EUCTR2014-000226-38-GB (EUCTR) | 08/01/2015 | 31/07/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 108 | EUCTR2014-000226-38-ES (EUCTR) | 02/01/2015 | 16/10/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 109 | EUCTR2014-000226-38-NL (EUCTR) | 22/12/2014 | 24/09/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 110 | EUCTR2014-000226-38-BE (EUCTR) | 17/12/2014 | 26/09/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 111 | EUCTR2014-001516-19-IT (EUCTR) | 10/12/2014 | 16/10/2014 | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Australia;Peru;South Africa;Netherlands;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | ||
| 112 | EUCTR2014-000226-38-DK (EUCTR) | 02/12/2014 | 11/09/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 113 | EUCTR2014-000226-38-SE (EUCTR) | 21/11/2014 | 14/08/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 114 | JPRN-UMIN000015715 | 2014/11/20 | 25/11/2014 | Clinical Efficacy Study of Tolvaptan on Patients with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Tolvaptan administration | Kyorin University School of Medicine | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 100 | Phase 4 | Japan | |
| 115 | EUCTR2014-001973-15-DK (EUCTR) | 18/11/2014 | 27/06/2014 | The effcts of tolvaptan on renal handling of water and salt, hormones in the blood at the circulation, during blocking of the nitric oxide (NO) system in patients with autosomal dominant polycystic kidney disease | Renal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease.The effects of tolvaptan on renal handling of water and sodium , vasoactive hormones and central hemodynamics during baseline conditions and after inhibition of the nitric oxide system in patients with autosomal dominant polycystic kidney disease - TOPO | HyponatreamiaSIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) OverhydrationAutosomal dominant polycystic kidney disease MedDRA version: 17.0;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 100000004861 MedDRA version: 17.0;Classification code 10040626;Term: SIADH;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Trade Name: Samsca Product Name: Tolvaptan Product Code: C03XA01 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN | University Clinic in Nephrology and Hypertension, Department of Medical Research | NULL | Not Recruiting | Female: yes Male: yes | Denmark | ||||
| 116 | EUCTR2014-000226-38-IT (EUCTR) | 11/11/2014 | 05/08/2014 | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | ||
| 117 | EUCTR2014-000226-38-HU (EUCTR) | 03/11/2014 | 21/08/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 118 | NCT02251275 (ClinicalTrials.gov) | October 17, 2014 | 25/9/2014 | Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney, Autosomal Dominant | Drug: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | N/A | All | 1803 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Czechia;Denmark;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Romania;Russian Federation;South Africa;Spain;Sweden;United Kingdom;Czech Republic |
| 119 | NCT02134899 (ClinicalTrials.gov) | October 14, 2014 | 28/4/2014 | The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients | An Open-labelled Multicenter Randomized Study on the Efficacy of Everolimus in Reducing Total Native Kidney Volume in Kidney Transplanted Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: Everolimus;Drug: Calcineurin inhibitors maintenance | Assistance Publique - Hôpitaux de Paris | Novartis | Completed | 18 Years | 75 Years | All | 3 | Phase 3 | France |
| 120 | JPRN-UMIN000015245 | 2014/09/25 | 25/09/2014 | Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment. | Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment. - ADPKD confirmatory study to establish the determinants of disease progression and response to tolvaptan treatment. | autosomal dominant polycystic kidney disease (ADPKD) | tolvaptan 60~120mg/day tolvaptan less than 60mg/day (in case of minimize dose recommended, for example; kidney dysfunction) tolvaptan less than 60mg/day (in case of minimize dose recommended, for example; kidney dysfunction) no medication tolvaptan less than 60mg/day of start dose (in case of minimize start dose recommended, for example; less than 20 years old or more than 65 years old) | Department of Nephrology, Tokyo Women's Medical University | NULL | Complete: follow-up complete | 15years-old | Not applicable | Male and Female | 100 | Not applicable | Japan |
| 121 | NCT02127437 (ClinicalTrials.gov) | September 19, 2014 | 2/4/2014 | Lanreotide In Polycystic Kidney Disease Study | Lanreotide In Polycystic Kidney Disease Study | Autosomal Dominant Polycystic Kidney Disease (ADPKD | Drug: Lanreotide;Drug: saline | Assistance Publique - Hôpitaux de Paris | IPSEN pharmaceutical company, Boulogne-Billancourt, France | Completed | 18 Years | N/A | All | 159 | Phase 3 | France |
| 122 | JPRN-UMIN000012865 | 2014/06/30 | 01/03/2014 | Ursodeoxycholic acid for polycystic liver disease | Ursodeoxycholic acid for polycystic liver disease - UDCA for PLD | polycystic liver disease, polycystic kidney disease | UDCA 600mg/day standard treatment | Nephrology Center, Toranomon Hospital | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 100 | Not selected | Japan |
| 123 | NCT02160145 (ClinicalTrials.gov) | May 2014 | 6/6/2014 | Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Chronic Kidney Disease;Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan (OPC-41061);Drug: Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 65 Years | All | 1370 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Sweden;United Kingdom;Czech Republic |
| 124 | NCT02225860 (ClinicalTrials.gov) | May 2014 | 20/8/2014 | Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease | Low Osmolar Diet and Adjusted Water Intake for Vasopressin Suppression in ADPKD | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Behavioral: Diet and water adjustment | Tufts Medical Center | NULL | Completed | 18 Years | 60 Years | All | 34 | Phase 2/Phase 3 | United States |
| 125 | NCT02140814 (ClinicalTrials.gov) | May 2014 | 14/5/2014 | Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease | Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease | Polycystic Kidney Disease | Dietary Supplement: Niacinamide | Alan Yu, MB, BChir | NULL | Completed | 18 Years | 50 Years | Both | 10 | Phase 2 | United States |
| 126 | NCT02115659 (ClinicalTrials.gov) | April 2014 | 14/4/2014 | Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Randomized Controlled Trial of Triptolide-Containing Formulation for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Triptolide-Containing Formulation;Drug: Placebo | Shanghai Changzheng Hospital | NULL | Recruiting | 40 Years | 75 Years | Both | 100 | Phase 3 | China |
| 127 | NCT02055079 (ClinicalTrials.gov) | April 2014 | 31/1/2014 | Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease | Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease - The Vienna RAP Study | Polycystic Kidney, Type 1 Autosomal Dominant Disease;Polycystic Kidney, Type 2 Autosomal Dominant Disease | Drug: Sirolimus;Drug: Placebo | Medical University of Vienna | NULL | Unknown status | 18 Years | N/A | All | 68 | Phase 3 | Austria |
| 128 | NCT02847624 (ClinicalTrials.gov) | March 2014 | 25/7/2016 | Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD | Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in Japan | Polycystic Kidney, Autosomal Dominant | Drug: tolvaptan | Otsuka Pharmaceutical Co., Ltd. | NULL | Recruiting | N/A | N/A | All | 1600 | Japan | |
| 129 | NCT02166489 (ClinicalTrials.gov) | March 2014 | 14/6/2014 | Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease | Evaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease | Chronic Renal Failure;Polycystic Kidney Disease | Biological: Intravenous injection autologous mesenchymal stem cells | Royan Institute | NULL | Completed | 18 Years | 60 Years | Both | 6 | Phase 1 | Iran, Islamic Republic of |
| 130 | EUCTR2012-000550-60-AT (EUCTR) | 17/01/2014 | 27/11/2013 | Pulsed oral sirolimus in autosomal dominant polycystic kidney disease | Pulsed oral sirolimus in autosomal dominant polycystic kidney disease - The Vienna RAP Study | Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disorder characterized by the development and uncontrolled proliferation of innumerable epithelial-lined cysts that stem from renal tubular cells, which compress and/or destroy vital renal tissue with a gradual decline in renal function, and terminal kidney failure with the need for renal reaplacement therapy. As yet, other than supportive care there is no viable therapy. MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Rapamune 1mg tablets Product Name: Rapamune 1mg tablets INN or Proposed INN: SIROLIMUS | Medizinische Universität Wien, Klinische Abteilung für Nephrologie und Dialyse, Universitätsklinik für Innere Medizin 3 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 68 | Phase 3 | Austria | ||
| 131 | NCT02021110 (ClinicalTrials.gov) | December 2013 | 12/12/2013 | Ursodeoxycholic Acid as Treatment for Polycystic Liver Disease | An International, Multicenter, Randomized Controlled Clinical Trial Assessing the Efficacy of Ursodeoxycholic Acid as a Volume Reducing Treatment in Symptomatic Polycystic Liver Disease | Polycystic Liver Disease;Polycystic Kidney, Autosomal Dominant | Drug: Ursodeoxycholic Acid | Radboud University | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Completed | 18 Years | 80 Years | All | 34 | Phase 2 | Netherlands;Spain |
| 132 | EUCTR2013-003207-19-NL (EUCTR) | 29/11/2013 | 08/08/2013 | Trial to investigate the effect of ursodeoxycholic acid as a treatment of symptoms in polycystic liver disease: the CURSOR-trial | An international, multicenter, randomized controlled clinical trial assessing the efficacy of Ursodeoxycholic acid as a volume reducing treatment for symptomatic polycystic livers - The CURSOR trial | Patients suffering from symptomatic polycystic liver disease (PLD) with underlying diagnosis of isolated polycystic liver disease (PCLD) or autosomal dominant kidney disease (ADPKD);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: URSOCHOL 300 | Radboud University Nijmegen Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 4 | Spain;Netherlands | ||
| 133 | NCT01932450 (ClinicalTrials.gov) | August 2013 | 18/8/2013 | Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control | A Randomized, Open-label Study Investigating the Effect of Bilateral Renal Artery Sympathetic Denervation by Catheter-based Radiofrequency Ablation on Blood Pressure and Disease Progression in Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease;Hypertension | Procedure: renal sympathetic denervation;Drug: antihypertensive drugs | Mei changlin | NULL | Recruiting | 20 Years | 60 Years | Both | 100 | Phase 2 | China |
| 134 | NCT01853553 (ClinicalTrials.gov) | July 2013 | 8/5/2013 | Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney | ADPKD | Drug: Spironolactone;Drug: Sugar pill | University of Colorado, Denver | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 20 Years | 55 Years | All | 61 | Phase 3 | United States |
| 135 | NCT01559363 (ClinicalTrials.gov) | September 2012 | 9/3/2012 | A Safety, Pharmacokinetic & Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease | A Phase 1b/2a, Safety, Pharmacokinetic and Dose-Escalation Study of KD019 ((Tesevatinib) in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Polycystic Kidney, Autosomal Dominant | Drug: KD019 (tesevatinib) | Kadmon Corporation, LLC | NULL | Completed | 22 Years | 62 Years | All | 74 | Phase 1/Phase 2 | United States |
| 136 | NCT01670110 (ClinicalTrials.gov) | August 2012 | 17/8/2012 | Pasireotide LAR in Severe Polycystic Liver Disease | A Randomized, Placebo Controlled Clinical Trial of SOM230 (Pasireotide LAR) In Severe Polycystic Liver Disease | Somatostatin Analogs;Polycystic Liver Disease;Autosomal Dominant Polycystic Kidney Disease;Autosomal Dominant Polycystic Liver Disease | Drug: Pasireotide LAR;Drug: Placebo | Mayo Clinic | NULL | Completed | 18 Years | 100 Years | All | 48 | Phase 2 | United States |
| 137 | NCT01616927 (ClinicalTrials.gov) | June 2012 | 6/6/2012 | Study of Lanreotide to Treat Polycystic Kidney Disease | The DIPAK 1 Study: A Randomised, Controlled Clinical Trial Assessing the Efficacy of Lanreotide to Halt Disease Progression in ADPKD | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Lanreotide | University Medical Center Groningen | Leiden University Medical Center;Erasmus Medical Center;Radboud University | Active, not recruiting | 18 Years | 60 Years | All | 300 | Phase 3 | Netherlands |
| 138 | EUCTR2011-005017-37-NL (EUCTR) | 30/05/2012 | 21/05/2012 | To investigate the effect of Lanreotide on renal function decline in ADPKD patients | A randomised, controlled clinical trial assessing the efficacy ofLanreotide to halt disease progression in ADPKD - The DIPAK 1 Study | First, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measuredby change in rate of renal function decline and change in renal volume. Second, to demonstrate whether Lanreotidemodifies progression of the liver phenotype in the subset of ADPKD patients with moderate to severe polycystic liverdisease as measured by change in liver volume. MedDRA version: 14.1;Level: LLT;Classification code 10023433;Term: Kidney polycystic;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Somatuline Autogel Product Name: Lanreotide Product Code: BIM 23014 INN or Proposed INN: Lanreotide Other descriptive name: LANREOTIDE ACETATE | DIPAK Consortium | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 139 | EUCTR2010-023017-65-BG (EUCTR) | 14/05/2012 | 22/05/2012 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden | ||
| 140 | EUCTR2010-023017-65-LT (EUCTR) | 14/11/2011 | 02/09/2011 | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden | ||
| 141 | EUCTR2010-023017-65-IT (EUCTR) | 28/10/2011 | 14/03/2012 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF 05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD). | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: BOSUTINIB Other descriptive name: SKI-606 | PFIZER INC. | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Australia;Japan;Sweden | ||
| 142 | NCT01451827 (ClinicalTrials.gov) | October 2011 | 11/10/2011 | 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Placebo-masked, Parallel-group Pilot Trial to Compare the Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and Immediate-release Formulations in Subjects With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan MR;Drug: Tolvaptan IR;Drug: Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 50 Years | All | 178 | Phase 2 | United States |
| 143 | NCT01680250 (ClinicalTrials.gov) | September 2011 | 30/8/2012 | Sirolimus for Massive Polycystic Liver | An Open-label, Prospective Clinical Trial to Evaluate the Effectiveness and Safety of Sirolimus to Reduce Cyst Growth in ADPKD Patients With Massive Polycystic Liver | Polycystic Kidney Diseases | Drug: Sirolimus | Seoul National University Hospital | Wyeth is now a wholly owned subsidiary of Pfizer | Recruiting | 18 Years | 65 Years | Both | 44 | Phase 2/Phase 3 | Korea, Republic of |
| 144 | EUCTR2010-023017-65-GB (EUCTR) | 02/08/2011 | 08/04/2011 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Germany;Japan;Sweden | ||
| 145 | EUCTR2010-023017-65-CZ (EUCTR) | 16/06/2011 | 01/02/2011 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Japan;Moldova, Republic of;Sweden | ||
| 146 | EUCTR2010-023017-65-HU (EUCTR) | 27/05/2011 | 05/04/2011 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Germany;Japan;Moldova, Republic of;Sweden | ||
| 147 | EUCTR2010-023017-65-SK (EUCTR) | 25/05/2011 | 28/04/2011 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden | ||
| 148 | NCT01354405 (ClinicalTrials.gov) | May 2011 | 13/5/2011 | Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE) | The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease | Polycystic Liver Disease | Drug: Lanreotide | Radboud University | Ipsen | Completed | 18 Years | 70 Years | Both | 43 | N/A | Netherlands |
| 149 | NCT01377246 (ClinicalTrials.gov) | May 2011 | 20/6/2011 | Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency | A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL TO ASSESS THE EFFECTS OF LONG-ACTING SOMATOSTATIN (OCTREOTIDE LAR) THERAPY ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE TO SEVERE RENAL INSUFFICIENCY | Autosomal Dominant Polycystic Kidney Disease | Drug: Octreotide-LAR;Other: Saline solution. | Mario Negri Institute for Pharmacological Research | NULL | Completed | 18 Years | 75 Years | All | 100 | Phase 3 | Italy |
| 150 | EUCTR2010-023017-65-PL (EUCTR) | 21/04/2011 | 12/04/2011 | A multicenter, randomized, double-blind, placebo-controlled study of thesafety, effectiveness, and pharmacokinetics of bosutinib versus placebo insubjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Czech Republic;Slovakia;Spain;Poland;Lithuania;Italy;United Kingdom;Sweden | ||
| 151 | EUCTR2011-000138-12-IT (EUCTR) | 04/04/2011 | 28/12/2011 | A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2 | A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2 | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: SANDOSTATINA LAR INN or Proposed INN: Octreotide | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy | ||
| 152 | ChiCTR-TRC-11001282 | 2011-04-01 | 2011-04-21 | Triptolide Retards Autosomal Dominant Polycystic Kidney Disease with Proteinuria | Triptolide Retards Autosomal Dominant Polycystic Kidney Disease with Proteinuria | Autosomal dominant polycystic kidney disease;Q61.301 | Group A:Glucosidorum Tripterygll Totorum+losartan potassium ;Group B:Placebo + losartan potassium; | Shanghai Changzheng Hospital | NULL | Completed | 18 | 55 | Both | Group A:30;Group B:30; | China | |
| 153 | EUCTR2009-017849-57-NL (EUCTR) | 24/03/2011 | 13/01/2010 | Somatostatin analogues as a volume reducing treatment of polycystic livers - SOLVE | Somatostatin analogues as a volume reducing treatment of polycystic livers - SOLVE | Polycystic liver disease, due to isolated polycystic liver disease or polycystic kidney disease. MedDRA version: 12.1;Level: LLT;Classification code 10048834;Term: Polycystic liver disease MedDRA version: 12.1;Level: PT;Classification code 10036045;Term: Polycystic kidney MedDRA version: 12.1;Classification code 10036046;Term: Polycystic kidney, autosomal dominant MedDRA version: 12.1;Classification code 10036048;Term: Polycystic kidney, unspecified type | Product Name: Sandostatin LAR Product Code: unknown Product Name: Somatuline Autosolution Product Code: unknown | Radboud University Nijmegen Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 154 | EUCTR2010-023017-65-ES (EUCTR) | 18/03/2011 | 27/01/2011 | ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD). | ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD). | Poliquistosis renal autosómica dominante (PRAD). MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | PFIZER, S.L.U. | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden | ||
| 155 | EUCTR2010-023017-65-SE (EUCTR) | 17/03/2011 | 20/01/2011 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden | ||
| 156 | EUCTR2010-018401-10-NL (EUCTR) | 14/01/2011 | 21/10/2010 | A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys. | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Samsca Product Name: Tolvaptan Product Code: OPC-41061 INN or Proposed INN: Tolvaptan INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1500 | France;United States;Canada;Poland;Belgium;Romania;Russian Federation;Afghanistan;Germany;Netherlands;Italy;United Kingdom | |||
| 157 | NCT01233869 (ClinicalTrials.gov) | December 2010 | 28/10/2010 | Bosutinib For Autosomal Dominant Polycystic Kidney Disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety, Clinical Activity And Pharmacokinetics Of Bosutinib (PF-05208763) Versus Placebo In Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Polycystic Kidney, Autosomal Dominant | Drug: Bosutinib;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | 50 Years | All | 172 | Phase 2 | United States;Australia;Canada;Czech Republic;Hungary;Italy;Korea, Republic of;Lithuania;Moldova, Republic of;Poland;Romania;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 158 | EUCTR2010-018401-10-IT (EUCTR) | 24/11/2010 | 10/09/2010 | Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) - ND | Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) - ND | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 9.1;Level: LLT;Classification code 10036046 | OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC | NULL | Not Recruiting | Female: yes Male: yes | 1500 | France;Netherlands;Germany;United Kingdom;Italy | ||||
| 159 | EUCTR2010-018401-10-BE (EUCTR) | 23/11/2010 | 03/09/2010 | A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys. | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Samsca 15 mg tablets Product Name: Tolvaptan 15 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 160 | EUCTR2010-018401-10-FR (EUCTR) | 15/11/2010 | 27/07/2010 | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Trade Name: Samsca 15 mg tablets Product Name: Tolvaptan 15 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 161 | JPRN-JapicCTI-101362 | 01/11/2010 | 03/12/2010 | A multicenter, open-label extension study to investigate the long-term safety and efficacy of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) [Extension of Trial 156-04-251] | A multicenter, open-label extension study to investigate the long-term safety and efficacy of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) [Extension of Trial 156-04-251] | Autosomal dominant polycystic kidney disease (ADPKD) | Intervention name : Tolvaptan Dosage And administration of the intervention : Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg. | Otsuka Pharmaceutical Co., Ltd. | NULL | 23 | 53 | BOTH | 150 | Phase 3 | NULL | |
| 162 | NCT01280721 (ClinicalTrials.gov) | November 2010 | 6/12/2010 | A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan] | A Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan] | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: tolvaptan | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 23 Years | 53 Years | All | 135 | Phase 3 | Japan |
| 163 | EUCTR2010-018401-10-GB (EUCTR) | 05/10/2010 | 26/08/2010 | A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys. | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Samsca 15 mg tablets Product Name: Tolvaptan 15 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 164 | NCT01210560 (ClinicalTrials.gov) | October 2010 | 21/9/2010 | Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD | A Multi-center, Parallel-group, Randomized, Double-blind, Placebo-masked, Multiple Dose Trial of Modified-release (MR) and Immediate-release (IR) Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan MR;Drug: Tolvaptan IR | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 50 Years | All | 25 | Phase 2 | United States |
| 165 | NCT01336972 (ClinicalTrials.gov) | October 2010 | 15/4/2011 | Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 2a, Single-center Study Investigating the Short-term Renal Hemodynamic Effects, Safety and Pharmacokinetics/ Pharmacodynamics of Oral Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 70 Years | All | 29 | Phase 2 | Netherlands |
| 166 | NCT01223755 (ClinicalTrials.gov) | September 2010 | 12/10/2010 | Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency | EFFECTS OF SIROLIMUS ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND SEVERE RENAL INSUFFICIENCY | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Sirolimus;Drug: conventional therapy | Mario Negri Institute for Pharmacological Research | NULL | Terminated | 18 Years | 80 Years | Both | 41 | Phase 2/Phase 3 | Italy |
| 167 | EUCTR2010-019025-33-NL (EUCTR) | 31/08/2010 | 27/07/2010 | A Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function | A Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Trade Name: Samsca 15 mg tablets Product Name: Tolvaptan 15 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Netherlands | ||
| 168 | EUCTR2010-018401-10-DE (EUCTR) | 07/07/2010 | 10/06/2010 | A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys. | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Samsca 15 mg tablets Product Name: Tolvaptan 15 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1500 | France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom | |||
| 169 | NCT01214421 (ClinicalTrials.gov) | May 2010 | 26/9/2010 | Open-Label Tolvaptan Study in Subjects With ADPKD | Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | N/A | All | 1083 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Romania;Russian Federation;United Kingdom |
| 170 | EUCTR2009-012376-27-IT (EUCTR) | 16/11/2009 | 30/11/2009 | EFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN II | EFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN II | Polycystic Kidney MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Trade Name: SANDOSTATINA LAR INN or Proposed INN: Octreotide | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | Italy | ||
| 171 | NCT01632605 (ClinicalTrials.gov) | November 2009 | 13/5/2012 | The Vienna RAP Pilot Study | Rapamycin in Advanced Polycystic Kidney Disease Pilot Study | ADPKD | Drug: Sirolimus | Medical University of Vienna | NULL | Completed | 18 Years | N/A | Both | 8 | N/A | Austria |
| 172 | NCT01022424 (ClinicalTrials.gov) | November 2009 | 27/11/2009 | A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002] | A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002] | Autosomal Dominant Polycystic Kidney Disease | Drug: OPC-41061 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 13 | Phase 3 | Japan |
| 173 | NCT00890279 (ClinicalTrials.gov) | July 2009 | 28/4/2009 | Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD) | Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB | Kidney, Polycystic, Autosomal Dominant | Drug: Cilnidipine;Drug: Imidapril | Ministry of Health, Labour and Welfare, Japan | NULL | Recruiting | 20 Years | 60 Years | Both | 160 | Phase 2 | Japan |
| 174 | NCT00920309 (ClinicalTrials.gov) | June 2009 | 12/6/2009 | Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy | Rapamycin as Treatment for ADPKD: The Role of Biomarkers in Predicting a Response to Therapy | Autosomal Dominant Polycystic Kidney Disease | Drug: Rapamycin;Other: Standard of Care-Placebo | Yale University | NULL | Terminated | 18 Years | 70 Years | All | 21 | Phase 2/Phase 3 | United States |
| 175 | NCT02119013 (ClinicalTrials.gov) | January 2009 | 17/4/2014 | Effects of Somatostatin on ADPKD Heart | EFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A MATCHED-COHORT, SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDY | Autosomal Dominant Polycystic Kidney Disease;Glomerular Filtration Rate > 40 ml/Min | Drug: Octeotride;Drug: Placebo | Federico II University | NULL | Completed | 18 Years | 80 Years | Both | 35 | Phase 2/Phase 3 | NULL |
| 176 | NCT02119052 (ClinicalTrials.gov) | January 2009 | 17/4/2014 | Effects of Somatostatin on Liver in ADPKD | Effect of Long-acting Somatostatin on Liver in Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: octeotride;Drug: placebo | Federico II University | NULL | Completed | 18 Years | N/A | Both | 35 | Phase 2/Phase 3 | NULL |
| 177 | NCT00784030 (ClinicalTrials.gov) | November 2008 | 31/10/2008 | High Water Intake to Slow Progression of Polycystic Kidney Disease | The Effect of Water Loading on Urinary Biomarkers | Kidney, Polycystic, Autosomal Dominant | Other: Water | New York University School of Medicine | NULL | Completed | 18 Years | 65 Years | All | 23 | N/A | United States |
| 178 | NCT00801268 (ClinicalTrials.gov) | November 2008 | 25/11/2008 | Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease | Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Polycystic Kidney | Drug: tripterygium wilfordii;Drug: Emodin | Zhi-Hong Liu, M.D. | NULL | Terminated | 15 Years | 70 Years | Both | 300 | N/A | China |
| 179 | NCT00759369 (ClinicalTrials.gov) | September 2008 | 24/9/2008 | Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Water as Therapy in Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Other: Water prescription | University of Kansas | NULL | Completed | 18 Years | 50 Years | Both | 11 | N/A | United States |
| 180 | NCT01009957 (ClinicalTrials.gov) | June 2008 | 6/11/2009 | Everolimus on CKD Progression in ADPKD Patients | Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients | Polycystic Kidney Diseases | Drug: Everolimus | A. Manzoni Hospital | NULL | Terminated | 18 Years | N/A | Both | 71 | Phase 2/Phase 3 | Italy |
| 181 | NCT00771888 (ClinicalTrials.gov) | April 2008 | 13/10/2008 | Open-Label Extension of LOCKCYST Trial | Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers | Polycystic Liver Disease;Hepatomegaly;Liver Diseases;Polycystic Kidney;Autosomal Dominant | Drug: lanreotide | Radboud University | Ipsen | Active, not recruiting | 18 Years | 88 Years | Both | 54 | Phase 2/Phase 3 | Belgium;Netherlands |
| 182 | EUCTR2007-005047-21-IT (EUCTR) | 24/12/2007 | 02/07/2008 | Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA II | Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA II | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 9.1;Level: LLT;Classification code 10010428;Term: Congenital cystic kidney disease | Trade Name: RAPAMUNE*100CPR RIV 1MG INN or Proposed INN: Sirolimus Trade Name: RAPAMUNE*30CPR RIV 2MG INN or Proposed INN: Sirolimus | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Italy | ||
| 183 | EUCTR2007-006557-25-IT (EUCTR) | 20/12/2007 | 18/12/2007 | RAPAMYCIN FOR TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE - RAPYD-STUDY | RAPAMYCIN FOR TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE - RAPYD-STUDY | ADPKD type I MedDRA version: 9.1;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders | Trade Name: RAPAMUNE*100CPR RIV 1MG INN or Proposed INN: Sirolimus Product Name: Ramipril INN or Proposed INN: Ramipril | AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 184 | NCT00541853 (ClinicalTrials.gov) | December 2007 | 9/10/2007 | CCB Safety Study in Treatment of Hypertension of ADPKD | Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients | Kidney, Polycystic, Autosomal Dominant | Drug: Candesartan;Drug: Candesartan and Cilnidipine;Drug: Candesartan plus non-CCB agents | Kyorin University | Ministry of Health, Labour and Welfare, Japan | Not yet recruiting | 20 Years | 60 Years | Both | 150 | Phase 4 | Japan |
| 185 | NCT00565097 (ClinicalTrials.gov) | October 2007 | 28/11/2007 | Lanreotide as Treatment of Polycystic Livers | Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers | Polycystic Liver Disease;Hepatomegaly;Liver Diseases;Polycystic Kidney, Autosomal Dominant | Drug: Placebo;Drug: Lanreotide | Radboud University | Ipsen | Completed | 18 Years | 88 Years | Both | 38 | Phase 2/Phase 3 | Belgium;Netherlands |
| 186 | EUCTR2006-001485-16-FR (EUCTR) | 20/08/2007 | 23/07/2007 | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | polycystic kidney disease MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease | Product Name: Certican Product Code: RAD001 INN or Proposed INN: Everolimus | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Austria;Germany | |||
| 187 | EUCTR2006-002768-24-DE (EUCTR) | 03/05/2007 | 15/12/2006 | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Denmark;Germany;Italy;United Kingdom | ||
| 188 | EUCTR2006-002768-24-GB (EUCTR) | 23/04/2007 | 07/12/2006 | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Denmark;Germany;Italy;United Kingdom | ||
| 189 | EUCTR2006-002768-24-FR (EUCTR) | 18/04/2007 | 29/12/2006 | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Belgium;Denmark;Germany;Italy;United Kingdom | ||
| 190 | EUCTR2006-002768-24-IT (EUCTR) | 16/04/2007 | 23/07/2007 | Phase III multicenter, double blind,placebo controlled, parallel arm trial to determine long-term safety and efficacy of oral tolvaptan tablet regimen in adult subjects with autosomal dominant polycystic kidney disease | Phase III multicenter, double blind,placebo controlled, parallel arm trial to determine long-term safety and efficacy of oral tolvaptan tablet regimen in adult subjects with autosomal dominant polycystic kidney disease | Autosomal dominant polycystic kidney disease MedDRA version: 14.1;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: tolvaptan Product Code: NA INN or Proposed INN: tolvaptan Product Name: tolvaptan Product Code: NA INN or Proposed INN: tolvaptan Product Name: tolvaptan Product Code: NA INN or Proposed INN: tolvaptan | OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Denmark;Germany;United Kingdom;Italy | ||
| 191 | EUCTR2006-002768-24-BE (EUCTR) | 26/03/2007 | 05/12/2006 | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Belgium;Denmark;Germany;Italy;United Kingdom | ||
| 192 | NCT00491517 (ClinicalTrials.gov) | March 2007 | 25/6/2007 | Sirolimus Treatment in Patients With Autosomal Dominant Polycystic Kidney Disease: Renal Efficacy and Safety | Sirolimus Treatment in Patients With ADPKD | Polycystic Kidney | Drug: Sirolimus;Drug: conventional therapy | Mario Negri Institute for Pharmacological Research | NULL | Completed | 18 Years | 80 Years | Both | 22 | Phase 2 | Italy |
| 193 | EUCTR2006-003427-37-IT (EUCTR) | 05/02/2007 | 27/12/2006 | Sirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - ND | Sirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - ND | Autosomal-Dominant Polycystic Kidney Disease ADPKD MedDRA version: 9.1;Level: LLT;Classification code 10010428;Term: Congenital cystic kidney disease | Trade Name: RAPAMUNE*30CPR RIV 1MG INN or Proposed INN: Sirolimus Trade Name: RAPAMUNE*30CPR RIV 2MG INN or Proposed INN: Sirolimus | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 16 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Italy | ||
| 194 | EUCTR2006-002768-24-DK (EUCTR) | 26/01/2007 | 29/11/2006 | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease - - | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease - - | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Denmark;Germany;Italy;United Kingdom | ||
| 195 | JPRN-JapicCTI-070402 | 25/1/2007 | 21/05/2007 | Tolvaptan efficacy and safety in management of polycystic kidney desease and its outcomes (TEMPO3/4) | A phase 3, multi-center, double-blind, placebo-controlled, parallel-arm trial to determine long-term safety and efficacy of oral tolvaptan regimens in adult subjects with autosomal dominant polycystic kidney disease (ADPKD) | Autosomal dominant polycystic kidney disease (ADPKD) | Intervention name : OPC-41061 (tolvaptan) INN of the intervention : Tolvaptan Dosage And administration of the intervention : Oral, 45/15 mg Intervention name : OPC-41061 (tolvaptan) INN of the intervention : Tolvaptan Dosage And administration of the intervention : Oral, 60/30 mg Intervention name : OPC-41061 (tolvaptan) INN of the intervention : Tolvaptan Dosage And administration of the intervention : Oral, 90/30 mg Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Oral | Otsuka Pharmaceutical Co., Ltd. | NULL | complete | 20 | 50 | BOTH | 1500 | Phase 3 | Japan, North America, South America, Europe, Oceania |
| 196 | NCT00426153 (ClinicalTrials.gov) | January 2007 | 22/1/2007 | Octreotide in Severe Polycystic Liver Disease | Pilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver Disease | Polycystic Kidney, Autosomal Dominant;Polycystic Liver Disease;Hepatomegaly;Liver Diseases;Kidney, Polycystic;Abdominal Pain | Drug: Octreotide;Drug: Placebo | Mayo Clinic | Novartis;National Center for Research Resources (NCRR) | Completed | 18 Years | 80 Years | All | 42 | Phase 2/Phase 3 | United States |
| 197 | NCT00428948 (ClinicalTrials.gov) | January 2007 | 26/1/2007 | Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney Disease, Autosomal Dominant | Drug: Tolvaptan;Drug: Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Co., Ltd. | Completed | 18 Years | 50 Years | All | 1445 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Netherlands;Poland;Romania;Russian Federation;United Kingdom |
| 198 | EUCTR2006-001485-16-AT (EUCTR) | 15/12/2006 | 16/11/2006 | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | polycystic kidney disease MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease | Product Name: Certican Tabletten Product Code: RAD001 INN or Proposed INN: Everolimus | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Austria;Germany | |||
| 199 | NCT00414440 (ClinicalTrials.gov) | December 2006 | 20/12/2006 | Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease | A Multicenter, Randomized, Placebo-controlled, Double-blind Study on the Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease (ESRD) in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease | Drug: Placebo;Drug: Everolimus | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 50 Years | All | 431 | Phase 4 | Austria;France;Germany |
| 200 | NCT00456365 (ClinicalTrials.gov) | November 2006 | 12/3/2007 | Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney, Autosomal Dominant | Drug: pravastatin;Drug: Placebo | University of Colorado, Denver | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 8 Years | 22 Years | All | 110 | Phase 3 | United States |
| 201 | EUCTR2006-001485-16-DE (EUCTR) | 25/10/2006 | 19/01/2007 | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | polycystic kidney disease MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease | Product Name: Certican Tabletten Product Code: RAD001 INN or Proposed INN: Everolimus | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Austria;Germany | |||
| 202 | NCT00286156 (ClinicalTrials.gov) | October 2006 | 1/2/2006 | Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney Diseases | Drug: Rapamune | The Cleveland Clinic | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | 18 Years | 75 Years | All | 30 | Phase 1/Phase 2 | United States |
| 203 | NCT00598377 (ClinicalTrials.gov) | September 2006 | 31/12/2007 | Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease | Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: Tetracosactin | Istanbul University | NULL | Completed | 20 Years | 56 Years | Both | 49 | N/A | Turkey |
| 204 | NCT00346918 (ClinicalTrials.gov) | June 2006 | 22/6/2006 | Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Sirolimus (Rapamune®) for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD): a Randomized Controlled Study. | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Sirolimus;Other: Standard | University of Zurich | NULL | Completed | 18 Years | 40 Years | Both | 100 | Phase 3 | Switzerland |
| 205 | NCT00345137 (ClinicalTrials.gov) | May 2006 | 24/6/2006 | Effects of Systemic NO-Inhibition on Renal Hemodynamics in Patiens With Polycystic Kidney Disease and Chronic Glomerulonephritis | Phase 1 Study of Systemic Effects of Ng-Monomethyl-L-Arginine on Renal Hemodynamics in Patients With Polycystic Kidney Disease and Chronic Glomerulonephritis | ADPKD;Glomerulonephritis | Drug: Ng-monomethyl-L-arginine (drug) | Regional Hospital Holstebro | NULL | Completed | 20 Years | 60 Years | Both | 75 | Phase 1 | NULL |
| 206 | NCT00841568 (ClinicalTrials.gov) | April 2006 | 9/2/2009 | A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001] | A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001] | Autosomal Dominant Polycystic Kidney Disease | Drug: OPC-41061 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 17 | Phase 2 | Japan |
| 207 | NCT00309283 (ClinicalTrials.gov) | April 2006 | 30/3/2006 | Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study | Effect of a Long-acting Somatostatin on Disease Progression in Nephropathy Due to Autosomal Dominant Polycystic Kidney Disease: a Long-term Three Year Follow up Study | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Long-acting somatostatin;Other: Saline solution | Mario Negri Institute for Pharmacological Research | NULL | Completed | 18 Years | 75 Years | Both | 78 | Phase 3 | Italy |
| 208 | EUCTR2005-005552-41-IT (EUCTR) | 20/02/2006 | 06/03/2007 | Effect of long-acting somatostatin on disease progression in nephropathy due to autosomal dominant polycystic disease a long-term three year follow-up study - ALADIN | Effect of long-acting somatostatin on disease progression in nephropathy due to autosomal dominant polycystic disease a long-term three year follow-up study - ALADIN | Autosomal Dominant Polycystic Kidney Disease ADPKD MedDRA version: 6.1;Level: SOC;Classification code 10038359 | Trade Name: Sandostatina Lar IM Fl 20mg +2F Product Name: octreotide INN or Proposed INN: Octreotide | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy | ||
| 209 | NCT00283686 (ClinicalTrials.gov) | January 2006 | 26/1/2006 | HALT Progression of Polycystic Kidney Disease Study A | HALT Progression of Polycystic Kidney Disease Study A | Kidney, Polycystic | Drug: Lisinopril;Drug: Telmisartan;Drug: Placebo;Other: Standard Blood Pressure Control;Other: Low Blood Pressure Control | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Boehringer Ingelheim;Merck Sharp & Dohme Corp.;Polycystic Kidney Disease Foundation;University of Pittsburgh;Washington University School of Medicine | Completed | 15 Years | 64 Years | All | 558 | Phase 3 | United States |
| 210 | NCT01885559 (ClinicalTrials.gov) | January 2006 | 17/6/2013 | HALT Progression of Polycystic Kidney Disease Study B | HALT Progression of Polycystic Kidney Disease Study B | Kidney, Polycystic | Drug: Lisinopril;Drug: Telmisartan;Drug: Placebo | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Boehringer Ingelheim;Merck Sharp & Dohme Corp.;Polycystic Kidney Disease Foundation;University of Pittsburgh;Washington University School of Medicine | Completed | 15 Years | 64 Years | All | 486 | Phase 3 | United States |
| 211 | NCT00413777 (ClinicalTrials.gov) | December 2005 | 18/12/2006 | Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 2, Multi-center, Open-label Study to Determine Long-term Safety, Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120 mg/d in Patients With Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney, Autosomal Dominant | Drug: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Co., Ltd. | Completed | 18 Years | N/A | All | 46 | Phase 2 | United States |
| 212 | EUCTR2005-003182-16-GB (EUCTR) | 26/08/2005 | 29/07/2005 | Blood Pressure Optimisation In Patients With Polycystic Kidney Disease And Hypertension By Rotation Through The Main Therapeutic Classes Of Antihypertensive Drugs. | Blood Pressure Optimisation In Patients With Polycystic Kidney Disease And Hypertension By Rotation Through The Main Therapeutic Classes Of Antihypertensive Drugs. | Polycystic kidney disease | Trade Name: CARDURA Product Name: DOXAZOSIN Trade Name: MONOCOR Product Name: BISOPROLOL Trade Name: ZESTRIL Product Name: LISINOPRIL Trade Name: ISTIN Product Name: AMLODIPINE Trade Name: AMIAS Product Name: CANDESARTAN Trade Name: APRINOX Product Name: BENDROFLUMETHIAZIDE | Addenbrooke's Hospital Trust | NULL | Not Recruiting | Female: yes Male: yes | 42 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 213 | NCT00067977 (ClinicalTrials.gov) | October 2003 | 3/9/2003 | Clinical Trial to Slow the Progression of ADPKD | Kidney, Polycystic;Kidney, Polycystic, Autosomal Dominant | Drug: anti-hypertensive medications | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Not yet recruiting | 15 Years | 65 Years | Both | N/A | United States | ||
| 214 | EUCTR2020-005991-36-DE (EUCTR) | 26/05/2021 | A trial to see if tolvaptan can delay dialysis in infants and children who at enrollment are 28 days to less than 12 weeks old with Autosomal Recessive Polycystic Kidney Disease (ARPKD) | A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 12 weeks of Age with Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Autosomal Recessive Polycystic Kidney Disease (ARPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036047;Term: Polycystic kidney, autosomal recessive;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 50mg Granules Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | NA | Female: yes Male: yes | 20 | Phase 3 | United States;Belgium;Germany;United Kingdom;Italy | |||
| 215 | EUCTR2020-005992-10-DE (EUCTR) | 26/05/2021 | A trial to see if tolvaptan is safe in infants and children who at enrollment are 28 days to less than 18 years old with Autosomal Recessive Polycystic Kidney Disease (ARPKD) | A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 18 years of Age with Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Autosomal Recessive Polycystic Kidney Disease (ARPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036047;Term: Polycystic kidney, autosomal recessive;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SAMSCA 7.5 mg oral tablet Product Name: Tolvaptan 7.5 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 15mg Tablet Product Name: Tolvaptan 15 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc 30 mg Tablet Product Name: Tolvaptan 30 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 50mg Granules Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | NA | Female: yes Male: yes | 10 | Phase 3 | United States;Belgium;Germany;United Kingdom;Italy | |||
| 216 | EUCTR2019-003521-21-ES (EUCTR) | 28/05/2020 | A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney disease | An exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, in subjects with autosomal dominant polycystic kidney disease | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Belgium;Spain;Germany;Netherlands;Italy |