67. 多発性嚢胞腎 Polycystic kidney disease Clinical trials / Disease details
臨床試験数 : 221 / 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 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 | NCT05373264 (ClinicalTrials.gov) | February 2023 | 28/4/2022 | HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life | HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life | ADPKD | Drug: Hydrochlorothiazide 25 mg;Drug: Placebo | University Medical Center Groningen | NULL | Not yet recruiting | 18 Years | 80 Years | All | 300 | Phase 3 | Belgium;France;Germany;Netherlands;Spain;United Kingdom;United States |
| 2 | NCT04939935 (ClinicalTrials.gov) | November 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 |
| 3 | NCT05510115 (ClinicalTrials.gov) | October 17, 2022 | 11/8/2022 | Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease | Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney, Autosomal Dominant | Drug: Empagliflozin;Drug: Placebo | University of Colorado, Denver | University of Maryland | Not yet recruiting | 18 Years | 50 Years | All | 50 | Phase 2 | United States |
| 4 | NCT05521191 (ClinicalTrials.gov) | October 6, 2022 | 24/8/2022 | A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease | A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study in Patients With Autosomal Dominant Polycystic Kidney Disease to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RGLS8429 | Autosomal Dominant Polycystic Kidney Disease;ADPKD;Polycystic Kidney, Autosomal Dominant | Drug: RGLS8429;Drug: Placebo | Regulus Therapeutics Inc. | NULL | Recruiting | 18 Years | 70 Years | All | 36 | Phase 1 | United States |
| 5 | NCT05190744 (ClinicalTrials.gov) | September 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 |
| 6 | NCT04782258 (ClinicalTrials.gov) | July 15, 2022 | 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 | Recruiting | 28 Days | 18 Years | All | 10 | Phase 3 | United States;Belgium;France;Germany;Italy;Poland;United Kingdom |
| 7 | NCT04786574 (ClinicalTrials.gov) | July 1, 2022 | 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 | Recruiting | 28 Days | 12 Weeks | All | 20 | Phase 3 | United States;Belgium;Germany;Italy;United Kingdom |
| 8 | NCT05401409 (ClinicalTrials.gov) | May 5, 2022 | 27/5/2022 | Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease | Double-Blind, Randomised Placebo-Controlled Study to Determine the Effect of Beetroot Juice on Reducing Blood Pressure in Hypertensive Adults With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney;Hypertension;Endothelial Dysfunction | Dietary Supplement: Beetroot juice;Dietary Supplement: Nitrate-depleted beetroot juice | Western Sydney Local Health District | Westmead Institute for Medical Research | Recruiting | 18 Years | 70 Years | All | 60 | N/A | Australia |
| 9 | NCT05228574 (ClinicalTrials.gov) | March 11, 2022 | 12/1/2022 | Treatment of Vascular Stiffness in ADPKD | Treatment of Vascular Stiffness in Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney | Dietary Supplement: Sodium chloride (NaCl);Dietary Supplement: Placebo;Drug: Amiloride Hcl 5mg Tab | Erasmus Medical Center | NULL | Recruiting | 18 Years | N/A | All | 54 | Phase 4 | Netherlands |
| 10 | 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 | Centessa Pharmaceuticals plc | Terminated | 18 Years | N/A | All | 1 | Phase 3 | United States |
| 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 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 | Autosomal Dominant Polycystic Kidney;ADPKD | Drug: Lixivaptan;Drug: Placebo | Palladio Biosciences | Centessa Pharmaceuticals plc | Terminated | 18 Years | 60 Years | All | 12 | Phase 3 | United States;Australia;Bulgaria;Hungary;Poland;Spain;Turkey;United Kingdom;Argentina;Canada;Chile;Israel;Italy;Mexico;Romania;Slovakia |
| 12 | NCT04908462 (ClinicalTrials.gov) | June 8, 2021 | 18/5/2021 | To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers | 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) | AceLink Therapeutics, Inc. | Novotech (Australia) Pty Limited | Completed | 18 Years | 55 Years | All | 69 | Phase 1 | Australia |
| 13 | NCT04705051 (ClinicalTrials.gov) | February 9, 2021 | 8/1/2021 | 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) | Congenital Cystic Kidney Disease | Drug: Venglustat GZ402671 | Sanofi | NULL | Terminated | 18 Years | N/A | All | 24 | Phase 3 | United States;Australia;Belgium;Germany;Japan;Korea, Republic of;Netherlands;Spain;France;Romania |
| 14 | 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 | Belgium;Czechia;Germany;Italy;Netherlands;Poland;Spain |
| 15 | 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 | NULL | Completed | 18 Years | 40 Years | All | 22 | United States | |
| 16 | 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 |
| 17 | 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 |
| 18 | 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;ADPKD | Drug: Lixivaptan | Palladio Biosciences | Centessa Pharmaceuticals plc | Terminated | 18 Years | 65 Years | All | 7 | Phase 3 | United States |
| 19 | 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 | Completed | 19 Years | 50 Years | All | 118 | Phase 4 | Korea, Republic of |
| 20 | 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 | 12 Years | 70 Years | All | 850 | Phase 3 | United States;Australia;Belgium;Czechia;France;Germany;Italy;Japan;Spain;United Kingdom |
| 21 | 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;Australia;France;Japan;Puerto Rico;Spain |
| 22 | 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 | ||
| 23 | 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: sodium citrate;Drug: Pravastatin | University of Southern California | NULL | Enrolling by invitation | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 24 | 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 |
| 25 | 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 |
| 26 | 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 | ||
| 27 | 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 |
| 28 | 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;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 |
| 29 | 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 |
| 30 | 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 |
| 31 | 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 | ||
| 32 | 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 |
| 33 | 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 |
| 34 | NCT03203642 (ClinicalTrials.gov) | October 12, 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, a Sanofi Company | NULL | Completed | 18 Years | 60 Years | All | 80 | Phase 2 | United States |
| 35 | 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 | Active, not recruiting | 25 Years | 60 Years | All | 150 | Phase 4 | United States |
| 36 | NCT03096080 (ClinicalTrials.gov) | August 24, 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 |
| 37 | 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 |
| 38 | 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 |
| 39 | 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 |
| 40 | NCT02964273 (ClinicalTrials.gov) | September 23, 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: Tolvaptan;Drug: Tolvaptan Matching-placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 4 Years | 17 Years | All | 91 | Phase 3 | Belgium;Germany;Italy;United Kingdom |
| 41 | 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 | |
| 42 | 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 |
| 43 | NCT02616055 (ClinicalTrials.gov) | December 25, 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 | 62 Years | All | 15 | Phase 2 | United States |
| 44 | 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 |
| 45 | 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 |
| 46 | 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 |
| 47 | 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 |
| 48 | 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 |
| 49 | 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 |
| 50 | 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 |
| 51 | 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 |
| 52 | 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 |
| 53 | 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 |
| 54 | NCT02847624 (ClinicalTrials.gov) | March 24, 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 | Active, not recruiting | N/A | N/A | All | 1600 | Japan | |
| 55 | 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 |
| 56 | 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 |
| 57 | NCT01559363 (ClinicalTrials.gov) | December 7, 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, a Sanofi Company | NULL | Completed | 18 Years | 62 Years | All | 74 | Phase 1/Phase 2 | United States |
| 58 | 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 |
| 59 | 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 |
| 60 | 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 |
| 61 | 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 |
| 62 | 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 | ||
| 63 | 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 | ||
| 64 | 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 |
| 65 | 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 |
| 66 | 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 |
| 67 | 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 |
| 68 | 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 |
| 69 | 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 | ||
| 70 | 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 |
| 71 | 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 |
| 72 | 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 |
| 73 | 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 |
| 74 | 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 |
| 75 | 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 |
| 76 | 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 |
| 77 | 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 |
| 78 | 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 | ||
| 79 | 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 |
| 80 | 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 |
| 81 | 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 |