67. Polycystic kidney
[
99 clinical trials,
110 drugs（DrugBank:
42 drugs),
28 target genes / 133 target pathways ]
Searched query = "Polycystic kidney"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04064346 | March 2020 | 9 September 2019 | Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease | A 52-Week, Phase 3, Double-blind, Placebo-controlled, Randomized Study of the Efficacy and Safety of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Polycystic Kidney Disease, Adult | Drug: Lixivaptan;Drug: Placebo | Palladio Biosciences | Not recruiting | 18 Years | 60 Years | All | 1200 | Phase 3 | ||
| 2 | NCT04152837 | February 2020 | 11 November 2019 | Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease | A Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Experienced Liver Function Test Abnormalities While Receiving Tolvaptan | Polycystic Kidney Disease, Adult | Drug: Lixivaptan | Palladio Biosciences | Not recruiting | 18 Years | 65 Years | All | 50 | Phase 3 | ||
| 3 | NCT03949894 | June 20, 2019 | 4 November 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. | Recruiting | 19 Years | 50 Years | All | 100 | Phase 4 | Korea, Republic of | |
| 4 | NCT03918447 | May 29, 2019 | 9 September 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. | Recruiting | 18 Years | 70 Years | All | 300 | Phase 3 | United States;Australia;Belgium;Czechia;France;Germany;Italy;Spain;United Kingdom | |
| 5 | NCT03717181 | May 22, 2019 | 22 July 2019 | 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 | Recruiting | 15 Years | 60 Years | All | 1 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | JPRN-jRCTs031180259 | 01/04/2019 | 10 September 2019 | Tolvaptan Intervention study and Genetic mutation of Autosomal Dominant Polycystic Kidney Disease | Tolvaptan Intervention study to Autosomal Dominant Polycystic Kidney Disease patients without Genetic mutation of disease gene - TIAG | ADPKD | Tolvaptan treatment | Shigeo Horie | Recruiting | 20 year | Not applicable | Both | 10 | N/A | None | |
| 7 | EUCTR2017-004084-12-NL | 13/02/2019 | 28 February 2019 | 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 Pharmaceutical Form: Capsule INN or Proposed INN: Venglustat CAS Number: 1401090-53-6 Current Sponsor code: GZ/SAR402671 Other descriptive name: Genz-682452-AU Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 Pharmaceutical Form: Capsule INN or Proposed INN: Venglustat CAS Number: 1401090-53-6 Current Sponsor code: GZ/SAR402671 Other descriptive name: Genz-682452-AU Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Genzyme Corporation | Authorised | Female: yes Male: yes | 836 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Germany;Netherlands;Japan;China;Korea, Republic of | |||
| 8 | JPRN-JapicCTI-184192 | 31/1/2019 | 16 July 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) | 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. | Recruiting | 18 | 50 | BOTH | 560 | Phase 2-3 | Japan, Asia except Japan, North America, Europe | |
| 9 | NCT03764605 | January 30, 2019 | 18 December 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 | Not recruiting | 18 Years | 50 Years | All | 150 | Phase 3 | Italy | |
| 10 | NCT03541447 | December 12, 2018 | 15 July 2019 | 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. | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | Italy |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03687554 | October 5, 2018 | 25 March 2019 | 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 | Not recruiting | 18 Years | 79 Years | All | 24 | Phase 1 | United States | |
| 12 | NCT03523728 | October 4, 2018 | 28 October 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) | Polycystic Kidney, Autosomal Dominant | Drug: Placebo;Drug: Venglustat GZ402671 | Genzyme, a Sanofi Company | Recruiting | 18 Years | 50 Years | All | 560 | Phase 2/Phase 3 | United States;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Romania;Spain;Taiwan;United Kingdom | |
| 13 | NCT03487913 | September 14, 2018 | 4 November 2019 | 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 | Recruiting | 18 Years | 65 Years | All | 32 | Phase 2 | United States | |
| 14 | NCT03596957 | September 12, 2018 | 3 December 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 | Recruiting | 18 Years | 65 Years | All | 90 | Phase 4 | Denmark | |
| 15 | EUCTR2017-003864-10-NL | 02/05/2018 | 5 June 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 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Metformin Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | University Medical Center Groningen | Authorised | Female: yes Male: yes | 12 | Phase 2 | Netherlands | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03423810 | April 23, 2018 | 8 April 2019 | 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 | Recruiting | 18 Years | 65 Years | All | 10 | Early Phase 1 | United States | |
| 17 | EUCTR2017-004115-39-DK | 08/02/2018 | 5 March 2018 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Other descriptive name: TOLVAPTAN Concentration unit: mg milligram(s) Concentration type: range Concentration number: 15-45 Trade Name: Jinarc 30 mg tablets, Jinarc 60 mg tablets Product Name: Jinarc - Tolvaptan tablets Product Code: 30 or 60 mg Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Other descriptive name: TOLVAPTAN Concentration unit: mg milligram(s) Concentration type: range Concentration number: 30-60 Trade Name: Jinarc 30 mg tablets, 90 mg tablets Product Name: Jinarc - Tolvaptan tablets Product Code: 30 or 90 mg Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Other descriptive name: TOLVAPTAN Concentration unit: mg milligram(s) Concentration type: range Concentration number: 30-90 | Nordsjællands Hospital, Department of Cardiology, Nephrology and Endocrinology | Authorised | Female: yes Male: yes | 90 | Phase 4 | Denmark | |||
| 18 | NCT03366337 | December 26, 2017 | 24 June 2019 | 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. | Not recruiting | 18 Years | 65 Years | All | 103 | Phase 2 | United States | |
| 19 | NCT03273413 | August 31, 2017 | 4 November 2019 | 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 | Recruiting | 25 Years | 60 Years | All | 200 | Phase 4 | United States | |
| 20 | NCT03203642 | August 9, 2017 | 11 November 2019 | 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 | Recruiting | 18 Years | 60 Years | All | 100 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT03096080 | June 14, 2017 | 11 November 2019 | 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 | Not recruiting | 5 Years | 12 Years | All | 10 | Phase 1 | United States | |
| 22 | NCT03102632 | June 1, 2017 | 17 June 2019 | 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 | Recruiting | 18 Years | 65 Years | All | 32 | N/A | United States |
| 23 | NCT02903511 | November 2016 | 14 October 2019 | 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) | Not recruiting | 30 Years | 60 Years | All | 50 | Phase 2 | United States |
| 24 | EUCTR2016-000187-42-GB | 24/10/2016 | 16 January 2017 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Current Sponsor code: OPC-41061 Other descriptive name: TOLVAPTAN (OPC-41061) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Jinarc® 15mg Tablet Product Name: Tolvaptan 15 mg Tablet Product Code: OPC-41061 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Current Sponsor code: OPC-41061 Other descriptive name: TOLVAPTAN (OPC-41061) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Jinarc® 30 Tablet Product Name: Tolvaptan 30 mg Tablet Product Code: OPC-41061 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Current Sponsor code: OPC-41061 Other descriptive name: TOLVAPTAN (OPC-41061) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Otsuka Pharmaceutical Development & Commercialization, Inc. | Authorised | Female: yes Male: yes | 100 | Phase 3 | Belgium;Germany;Italy;United Kingdom | |||
| 25 | NCT02729662 | October 1, 2016 | 26 August 2019 | 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 | Not recruiting | 18 Years | N/A | All | 118 | N/A | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT02933268 | September 26, 2016 | 28 January 2019 | 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 | Not recruiting | 16 Years | N/A | All | 42 | N/A | United Kingdom |
| 27 | NCT02964273 | September 2016 | 13 May 2019 | 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: Matching Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | Not recruiting | 4 Years | 17 Years | All | 91 | Phase 3 | Belgium;Germany;Italy;United Kingdom | |
| 28 | NCT02656017 | June 27, 2016 | 11 November 2019 | 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 | Not recruiting | 18 Years | 60 Years | All | 97 | Phase 2 | United States |
| 29 | NCT02697617 | January 26, 2016 | 11 March 2019 | 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 | Not recruiting | 18 Years | 55 Years | All | 18 | Phase 2 | United States | |
| 30 | EUCTR2014-001501-41-BE | 16/01/2016 | 8 August 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 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Current Sponsor code: Tolvaptan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- | Otsuka Pharmaceutical Development & Commercialization, Inc. | Authorised | Female: yes Male: yes | 20 | Phase 3 | France;United States;Argentina;Belgium;Germany;Japan | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT02616055 | December 2015 | 11 June 2018 | 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 | Not recruiting | 18 Years | 55 Years | All | 15 | Phase 2 | United States | |
| 32 | NCT03803124 | December 2015 | 21 January 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 | Not recruiting | 18 Years | N/A | All | 20 | Phase 3 | Denmark | |
| 33 | NCT02494141 | November 12, 2015 | 27 May 2019 | 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 | Recruiting | 6 Years | 25 Years | All | 68 | Phase 4 | United States | |
| 34 | NCT02558595 | September 22, 2015 | 25 February 2019 | 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) | Not recruiting | 18 Years | 60 Years | All | 36 | Phase 2 | United States |
| 35 | NCT02776241 | September 2015 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 40 | N/A | Denmark |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2015-001903-30-DK | 26/06/2015 | 29 January 2018 | 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 Pharmaceutical Form: Chewable tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Other descriptive name: TOLVAPTAN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Department of Medical Research | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Denmark | |||
| 37 | EUCTR2014-001516-19-GB | 26/03/2015 | 28 February 2019 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan Current Sponsor code: OPC-41061 Other descriptive name: TOLVAPTAN (OPC-41061) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Product Name: Tolvaptan 30mg Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan Current Sponsor code: OPC-41061 Other descriptive name: TOLVAPTAN (OPC-41061) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- | Otsuka Pharmaceutical Development & Commercialization, | Not Recruiting | 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;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | |||
| 38 | JPRN-UMIN000015715 | 2014/11/20 | 2 April 2019 | 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 | Not Recruiting | 18years-old | Not applicable | Male and Female | 100 | Phase 4 | Japan | ||
| 39 | EUCTR2014-001973-15-DK | 18/11/2014 | 11 April 2016 | 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 | Hyponatreamia SIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) Overhydration Autosomal dominant polycystic kidney disease MedDRA version: 17.0 Level: LLT Classification code 10021038 Term: Hyponatremia System Organ Class: 100000004861 MedDRA version: 17.0 Level: LLT 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 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Other descriptive name: TOLVAPTAN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | University Clinic in Nephrology and Hypertension, Department of Medical Research | Not Recruiting | Female: yes Male: yes | Denmark | |||||
| 40 | NCT02134899 | October 14, 2014 | 18 December 2018 | 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 | Not recruiting | 18 Years | 75 Years | All | 3 | Phase 3 | France |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | JPRN-UMIN000015245 | 2014/09/25 | 2 April 2019 | 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 Medicine four, Tokyo Women's Medical University | Recruiting | 15years-old | Not applicable | Male and Female | 100 | Not applicable | Japan | |
| 42 | NCT02127437 | September 19, 2014 | 8 January 2018 | 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 | Not recruiting | 18 Years | N/A | All | 156 | Phase 3 | France |
| 43 | NCT02251275 | September 2014 | 17 June 2019 | Open-label Trial to Evaluate the Long Term Safety of Titrated 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 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 | Drug: Tolvaptan (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | Not recruiting | 18 Years | N/A | All | 1814 | 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 | |
| 44 | NCT02140814 | May 2014 | 12 December 2016 | 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 | Not recruiting | 18 Years | 50 Years | Both | 10 | Phase 2 | United States | |
| 45 | NCT02160145 | May 2014 | 16 December 2017 | 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. | Not recruiting | 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 | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT02225860 | May 2014 | 16 December 2017 | 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 | Not recruiting | 18 Years | 60 Years | All | 34 | Phase 2/Phase 3 | United States | |
| 47 | NCT02115659 | April 2014 | 19 February 2015 | 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 | Recruiting | 40 Years | 75 Years | Both | 100 | Phase 3 | China | |
| 48 | NCT02166489 | March 2014 | 18 January 2016 | 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 | Not recruiting | 18 Years | 60 Years | Both | 6 | Phase 1 | Iran, Islamic Republic of | |
| 49 | NCT02847624 | March 2014 | 30 September 2019 | 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. | Recruiting | N/A | N/A | All | 1600 | N/A | Japan | |
| 50 | EUCTR2012-000550-60-AT | 17/01/2014 | 11 June 2018 | 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 Pharmaceutical Form: Coated tablet INN or Proposed INN: SIROLIMUS CAS Number: 53123-88-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Medizinische Universität Wien, Klinische Abteilung für Nephrologie und Dialyse, Universitätsklinik für Innere Medizin 3 | Authorised | Female: yes Male: yes | 68 | Phase 3 | Austria | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT02021110 | December 2013 | 18 April 2016 | 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 (PLD):;Polycystic Kidney, Autosomal Dominant;Polycystic Liver Disease | Drug: Ursodeoxycholic Acid | Radboud University | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);Biodonostia Health Research Institute | Not recruiting | 18 Years | 80 Years | Both | 34 | Phase 2 | Netherlands;Spain |
| 52 | NCT01932450 | August 2013 | 19 February 2015 | 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 | Recruiting | 20 Years | 60 Years | Both | 100 | Phase 2 | China | |
| 53 | NCT01853553 | July 2013 | 26 August 2019 | 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) | Not recruiting | 20 Years | 55 Years | All | 61 | Phase 3 | United States |
| 54 | NCT01559363 | September 2012 | 3 June 2019 | A Safety, Pharmacokinetic and Dose-Escalation Study of KD019 (Tesevatinib) in Subjects With ADPKD | A Phase 1b/2a, Safety, Pharmacokinetic and Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Polycystic Kidney, Autosomal Dominant | Drug: KD019 (tesevatinib) | Kadmon Corporation, LLC | Not recruiting | 22 Years | 62 Years | All | 74 | Phase 1/Phase 2 | United States | |
| 55 | NCT01670110 | August 2012 | 13 May 2019 | 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 | Not recruiting | 18 Years | 100 Years | All | 48 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT01451827 | October 2011 | 19 February 2015 | 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. | Not recruiting | 18 Years | 50 Years | Both | 178 | Phase 2 | United States | |
| 57 | NCT01680250 | September 2011 | 19 February 2015 | 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 |
| 58 | NCT01354405 | May 2011 | 19 February 2015 | 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 | Not recruiting | 18 Years | 70 Years | Both | 43 | N/A | Netherlands |
| 59 | NCT01377246 | May 2011 | 22 January 2018 | 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 | Not recruiting | 18 Years | 75 Years | All | 100 | Phase 3 | Italy | |
| 60 | ChiCTR-TRC-11001282 | 2011-04-01 | 18 April 2017 | 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 | Not Recruiting | 18 | 55 | Both | Group A:30;Group B:30; | Post-market | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | EUCTR2009-017849-57-NL | 24/03/2011 | 19 March 2012 | 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 10048834 Term: Polycystic liver disease MedDRA version: 12.1 Level: LLT Classification code 10036045 Term: Polycystic kidney MedDRA version: 12.1 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant MedDRA version: 12.1 Level: LLT Classification code 10036048 Term: Polycystic kidney, unspecified type | Product Name: Sandostatin LAR Product Code: unknown Pharmaceutical Form: Solution for injection Product Name: Somatuline Autosolution Product Code: unknown Pharmaceutical Form: Solution for injection | Radboud University Nijmegen Medical Centre | Authorised | Female: yes Male: yes | Netherlands | |||||
| 62 | NCT01233869 | December 2010 | 19 October 2017 | 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 | Not recruiting | 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 | |
| 63 | JPRN-JapicCTI-101362 | 01/11/2010 | 23 April 2019 | 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. | 23 | 53 | BOTH | 150 | Phase 3 | |||
| 64 | NCT01280721 | November 2010 | 26 October 2015 | 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. | Not recruiting | 23 Years | 53 Years | Both | 135 | Phase 3 | Japan | |
| 65 | NCT01210560 | October 2010 | 19 February 2015 | 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. | Not recruiting | 18 Years | 50 Years | Both | 25 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | EUCTR2010-019025-33-NL | 31/08/2010 | 19 March 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan Current Sponsor code: OPC-41061 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan Current Sponsor code: OPC-41061 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- | Otsuka Pharmaceutical Development Commercialization, Inc. | Not Recruiting | Female: yes Male: yes | 36 | Phase 2a | Netherlands | |||
| 67 | EUCTR2010-018401-10-DE | 07/07/2010 | 11 April 2016 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan Current Sponsor code: OPC-41061 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan Current Sponsor code: OPC-41061 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- | Otsuka Pharmaceutical Development & Commercialization, Inc | Not Recruiting | Female: yes Male: yes | 1500 | France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||||
| 68 | NCT01214421 | May 2010 | 11 June 2018 | 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. | Not recruiting | 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 | 16/11/2009 | 27 January 2014 | 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 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Octreotide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Intramuscular use | IST. DI RICERCHE FARMACOLOG. M. NEGRI | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 70 | NCT01022424 | November 2009 | 26 October 2015 | 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. | Not recruiting | N/A | N/A | Both | 13 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | NCT01632605 | November 2009 | 19 February 2015 | The Vienna RAP Pilot Study | Rapamycin in Advanced Polycystic Kidney Disease Pilot Study | ADPKD | Drug: Sirolimus | Medical University of Vienna | Not recruiting | 18 Years | N/A | Both | 8 | N/A | Austria | |
| 72 | NCT00890279 | July 2009 | 19 February 2015 | 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 | Recruiting | 20 Years | 60 Years | Both | 160 | Phase 2 | Japan | |
| 73 | NCT00920309 | June 2009 | 19 October 2017 | 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 | Not recruiting | 18 Years | 70 Years | All | 21 | Phase 2/Phase 3 | United States | |
| 74 | NCT02119013 | January 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | 80 Years | Both | 35 | Phase 2/Phase 3 | ||
| 75 | NCT02119052 | January 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 35 | Phase 2/Phase 3 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | NCT00784030 | November 2008 | 19 October 2017 | 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 | Not recruiting | 18 Years | 65 Years | All | 23 | N/A | United States | |
| 77 | NCT00801268 | November 2008 | 7 April 2015 | 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. | Not recruiting | 15 Years | 70 Years | Both | 300 | N/A | China | |
| 78 | NCT00759369 | September 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | 50 Years | Both | 11 | N/A | United States | |
| 79 | NCT01009957 | June 2008 | 3 August 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 71 | Phase 2/Phase 3 | Italy | |
| 80 | NCT00771888 | April 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | 88 Years | Both | 54 | Phase 2/Phase 3 | Belgium;Netherlands |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | EUCTR2007-005047-21-IT | 24/12/2007 | 24 July 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Sirolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Trade Name: RAPAMUNE*30CPR RIV 2MG Pharmaceutical Form: Tablet INN or Proposed INN: Sirolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | IST. DI RICERCHE FARMACOLOG. M. NEGRI | Not Recruiting | Female: yes Male: yes | Italy | ||||||
| 82 | EUCTR2007-006557-25-IT | 20/12/2007 | 10 July 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Sirolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Product Name: Ramipril Pharmaceutical Form: Tablet INN or Proposed INN: Ramipril Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- | AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 83 | NCT00565097 | October 2007 | 19 February 2015 | 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 | Not recruiting | 18 Years | 88 Years | Both | 38 | Phase 2/Phase 3 | Belgium;Netherlands |
| 84 | JPRN-JapicCTI-070402 | 01/7/2007 | 2 April 2019 | 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) Dosage And administration of the intervention : Oral, 45/15 mg Intervention name : OPC-41061 (tolvaptan) Dosage And administration of the intervention : Oral, 60/30 mg Intervention name : OPC-41061 (tolvaptan) Dosage And administration of the intervention : Oral, 90/30 mg Control intervention name : Placebo Dosage And administration of the control intervention : Oral | Otsuka Pharmaceutical Co., Ltd. | 20 | 50 | BOTH | 1500 | Phase 3 | |||
| 85 | EUCTR2006-003427-37-IT | 05/02/2007 | 19 March 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Sirolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Trade Name: RAPAMUNE*30CPR RIV 2MG Pharmaceutical Form: Tablet INN or Proposed INN: Sirolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | IST. DI RICERCHE FARMACOLOG. M. NEGRI | Not Recruiting | Female: yes Male: yes | Italy | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | EUCTR2006-002768-24-DK | 26/01/2007 | 20 May 2013 | 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) Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan Current Sponsor code: OPC-41061, OPC-156 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan Current Sponsor code: OPC-41061, OPC-156 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Otsuka Pharmaceutical Development & Commercialization, Inc. | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Denmark;Germany;Italy;United Kingdom | |||
| 87 | NCT00426153 | January 2007 | 19 October 2017 | 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) | Not recruiting | 18 Years | 80 Years | All | 42 | Phase 2/Phase 3 | United States |
| 88 | EUCTR2006-001485-16-AT | 15/12/2006 | 27 January 2014 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus Current Sponsor code: RAD001 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Novartis Pharma GmbH | Not Recruiting | Female: yes Male: yes | 300 | France;Austria;Germany | ||||
| 89 | NCT00456365 | November 2006 | 19 February 2015 | 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) | Not recruiting | 8 Years | 21 Years | Both | 112 | Phase 3 | United States |
| 90 | NCT00286156 | October 2006 | 19 October 2017 | 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 | Not recruiting | 18 Years | 75 Years | All | 30 | Phase 1/Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | NCT00598377 | September 2006 | 19 February 2015 | 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 | Not recruiting | 20 Years | 56 Years | Both | 49 | N/A | Turkey | |
| 92 | NCT00346918 | June 2006 | 19 February 2015 | 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 | Not recruiting | 18 Years | 40 Years | Both | 100 | Phase 3 | Switzerland | |
| 93 | NCT00345137 | May 2006 | 19 February 2015 | 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 | Not recruiting | 20 Years | 60 Years | Both | 75 | Phase 1 | ||
| 94 | NCT00309283 | April 2006 | 19 February 2015 | 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 | Not recruiting | 18 Years | 75 Years | Both | 78 | Phase 3 | Italy | |
| 95 | NCT00841568 | April 2006 | 19 February 2015 | 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. | Not recruiting | N/A | N/A | Both | 17 | Phase 2 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | NCT00283686 | January 2006 | 19 October 2017 | HALT Progression of Polycystic Kidney Disease (HALT PKD) Study A | Polycystic Kidney Disease-Treatment Network | 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 | Not recruiting | 15 Years | 64 Years | All | 558 | Phase 3 | United States |
| 97 | NCT01885559 | January 2006 | 19 October 2017 | HALT Progression of Polycystic Kidney Disease (HALT PKD) Study B | Polycystic Kidney Disease-Treatment Network | 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 | Not recruiting | 15 Years | 64 Years | All | 486 | Phase 3 | United States |
| 98 | NCT00413777 | December 2005 | 16 December 2017 | 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. | Not recruiting | 18 Years | N/A | All | 46 | Phase 2 | United States |
| 99 | EUCTR2005-003182-16-GB | 26/08/2005 | 24 April 2012 | 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 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: MONOCOR Product Name: BISOPROLOL Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: ZESTRIL Product Name: LISINOPRIL Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: ISTIN Product Name: AMLODIPINE Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: AMIAS Product Name: CANDESARTAN Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: APRINOX Product Name: BENDROFLUMETHIAZIDE Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Addenbrooke's Hospital Trust | Authorised | Female: yes Male: yes | 42 | United Kingdom |