67. Polycystic kidney disease
186 clinical trials,   196 drugs   (DrugBank: 47 drugs),   35 drug target genes,   146 drug target pathways

Searched query = "Polycystic kidney disease", "PKD", "PCKD", "Polycystic kidney", "ADPKD", "ARPKD"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
72 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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1NCT04064346
(ClinicalTrials.gov)
July 202119/8/2019Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney DiseaseA 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, AdultDrug: Lixivaptan;Drug: PlaceboPalladio BiosciencesNULLNot yet recruiting18 Years60 YearsAll1200Phase 3NULL
2NCT04578548
(ClinicalTrials.gov)
November 10, 20201/10/2020A 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, in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: GLPG2737;Drug: PlaceboGalapagos NVNULLRecruiting18 Years50 YearsAll60Phase 2Belgium;Germany;Netherlands;Poland;Spain
3NCT04407481
(ClinicalTrials.gov)
November 1, 202019/5/2020PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN)PENGUIN: PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKDPolycystic Kidney Disease, Adult;Polycystic Kidney, Autosomal DominantDrug: Aminohippurate Sodium Inj 20%;Drug: Iohexol Inj 300 milligrams per milliliter (MG/ML);Radiation: PET/CT ScanUniversity of Colorado Denver School of Medicine Barbara Davis CenterNULLRecruiting18 Years40 YearsAll20United States
4NCT04536688
(ClinicalTrials.gov)
October 202024/8/2020A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney DiseaseA 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 DiseasePolycystic Kidney Disease, Autosomal DominantDrug: RGLS4326Regulus Therapeutics Inc.NULLRecruiting18 Years70 YearsAll27Phase 1United States
5NCT04310319
(ClinicalTrials.gov)
September 7, 20203/3/2020Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and SaltWishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and SaltPolycystic Kidney, Autosomal Dominant;ADPKD;Autosomal Dominant Polycystic KidneyDietary Supplement: Sodiumchloride;Dietary Supplement: Protein;Dietary Supplement: Placebo comparator (salt);Dietary Supplement: Placebo comparator (protein)Esther MeijerNULLRecruiting18 YearsN/AAll12N/ANetherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
6NCT04152837
(ClinicalTrials.gov)
September 2, 202031/10/2019Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney DiseaseAn 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 StudyPolycystic Kidney Disease, AdultDrug: LixivaptanPalladio BiosciencesNULLRecruiting18 Years65 YearsAll50Phase 3United States
7NCT03949894
(ClinicalTrials.gov)
July 1, 201916/4/2019Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney DiseaseEvaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: TolvaptanKorea Otsuka Pharmaceutical Co., Ltd.NULLActive, not recruiting19 Years50 YearsAll118Phase 4Korea, Republic of
8NCT03918447
(ClinicalTrials.gov)
May 29, 201912/4/2019A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCONA Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney;ADPKDDrug: Bardoxolone methyl oral capsule;Drug: Placebo oral capsuleReata Pharmaceuticals, Inc.NULLRecruiting18 Years70 YearsAll300Phase 3United States;Australia;Belgium;Czechia;France;Germany;Italy;Japan;Spain;United Kingdom
9NCT03717181
(ClinicalTrials.gov)
May 22, 201922/10/2018Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney DiseaseExpanded Access Use of Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney DiseasePolycystic KidneyDrug: LixivaptanPalladio BiosciencesNULLActive, not recruiting15 Years60 YearsAll1Phase 2United States
10NCT03749447
(ClinicalTrials.gov)
March 8, 201919/11/2018An 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 DiseaseChronic Kidney Diseases;Alport Syndrome;Autosomal Dominant Polycystic KidneyDrug: Bardoxolone methylReata Pharmaceuticals, Inc.NULLRecruiting12 YearsN/AAll480Phase 3United States;Australia;Japan;Puerto Rico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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size
PhaseCountries
11NCT04284657
(ClinicalTrials.gov)
January 30, 201911/4/2019Pravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney DiseasePravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Pravastatin;Drug: sodium citrateUniversity of Southern CaliforniaNULLRecruiting18 YearsN/AAll30Phase 2United States
12NCT03764605
(ClinicalTrials.gov)
January 30, 201929/11/2018Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney DiseaseMetformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease. A Phase 3a, Indipendent, Multicentre, Two Parallel Arms, Randomized Controlled TrialADPKDDrug: Metformin;Drug: TolvaptanAzienda Ospedaliero-Universitaria Consorziale Policlinico di BariNULLNot yet recruiting18 Years50 YearsAll150Phase 3Italy
13NCT03541447
(ClinicalTrials.gov)
December 12, 201817/5/2018Tolvaptan-Octreotide LAR Combination in ADPKDA 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 HyperfiltrationAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan;Drug: Octreotide LAR;Other: PlaceboMario Negri Institute for Pharmacological ResearchOtsuka Pharmaceutical Italy S.r.l.Recruiting18 YearsN/AAll20Phase 2Italy
14EUCTR2018-000477-77-IT
(EUCTR)
08/11/201804/11/2020Evaluation 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 BARINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Italy
15NCT03687554
(ClinicalTrials.gov)
October 5, 201826/9/2018Effect of Venglustat in Patients With Renal ImpairmentA 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 FunctionHealthy Volunteers;Polycystic Kidney, Autosomal DominantDrug: Venglustat GZ/SAR402671Genzyme, a Sanofi CompanyNULLCompleted18 Years79 YearsAll24Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
16NCT03523728
(ClinicalTrials.gov)
October 4, 20181/5/2018A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD PatientsMulticenter, 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 DominantDrug: Venglustat GZ402671;Drug: PlaceboGenzyme, a Sanofi CompanyNULLRecruiting18 Years55 YearsAll640Phase 2;Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Romania;Spain;Taiwan;United Kingdom
17NCT03487913
(ClinicalTrials.gov)
September 14, 201816/3/2018The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseA Phase 2, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: LixivaptanPalladio BiosciencesNULLCompleted18 Years65 YearsAll31Phase 2United States
18NCT03596957
(ClinicalTrials.gov)
September 12, 201814/2/2018Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney DiseaseSubacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic KidneyDrug: TolvaptanLisbet BrandiNULLUnknown status18 Years65 YearsAll90Phase 4Denmark
19NCT03423810
(ClinicalTrials.gov)
April 23, 201831/1/2018Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease PatientsAssessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease PatientsPolycystic Kidney DiseasesDrug: HydralazineUniversity of Kansas Medical CenterNULLCompleted18 Years65 YearsAll14Early Phase 1United States
20NCT03366337
(ClinicalTrials.gov)
December 26, 20174/12/2017A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIXA Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney DiseasesIgA Nephropathy;CKD Associated With Type 1 Diabetes;Focal Segmental Glomerulosclerosis;Autosomal Dominant Polycystic KidneyDrug: Bardoxolone methyl capsulesReata Pharmaceuticals, Inc.NULLCompleted18 Years65 YearsAll103Phase 2United States
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
21NCT03273413
(ClinicalTrials.gov)
August 31, 20171/9/2017Statin Therapy in Patients With Early Stage ADPKDStatin Therapy in Patients With Early Stage ADPKDADPKD;Autosomal Dominant Polycystic KidneyDrug: Pravastatin;Drug: PlaceboUniversity of Colorado, DenverNULLRecruiting25 Years60 YearsAll200Phase 4United States
22NCT03203642
(ClinicalTrials.gov)
August 9, 201726/6/2017Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKDA Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney;ADPKDDrug: Tesevatinib;Drug: PlaceboKadmon Corporation, LLCNULLActive, not recruiting18 Years60 YearsAll80Phase 2United States
23NCT03096080
(ClinicalTrials.gov)
June 14, 20176/3/2017A 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 RecessiveDrug: TesevatinibKadmon Corporation, LLCNULLCompleted5 Years12 YearsAll10Phase 1United States
24NCT03102632
(ClinicalTrials.gov)
June 1, 201727/3/2017A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney DiseaseA Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic KidneyOther: High Water IntakeThe Rogosin InstituteWeill Medical College of Cornell UniversityRecruiting18 Years65 YearsAll32N/AUnited States
25NCT02903511
(ClinicalTrials.gov)
November 201613/9/2016Feasibility Study of Metformin Therapy in ADPKDFeasibility Study of Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease.Polycystic Kidney, Autosomal DominantDrug: Metformin;Drug: PlaceboUniversity of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed30 Years60 YearsAll52Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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size
PhaseCountries
26NCT02729662
(ClinicalTrials.gov)
October 1, 201611/3/2016Efficacy of Tolvaptan on ADPKD PatientsLongitudinal Efficacy and Safety Study of Tolvaptan on Autosomal Dominant Polycystic Kidney Disease Patients (LET-PKD Study)Autosomal Dominant Polycystic Kidney DiseaseDrug: TolvaptanKyorin UniversityNULLActive, not recruiting18 YearsN/AAll118N/AJapan
27NCT02933268
(ClinicalTrials.gov)
September 26, 201618/9/2016High Water Intake in Polycystic Kidney DiseaseDetermining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility TrialAutosomal Dominant Polycystic Kidney DiseaseDietary Supplement: High water intake;Other: Ad libitum water intakeCambridge University Hospitals NHS Foundation TrustPKD Charity;Addenbrookes Charitable Trust;British Renal Society & British Kidney Patient AssociationCompleted16 YearsN/AAll42N/AUnited Kingdom
28NCT02964273
(ClinicalTrials.gov)
September 201615/9/2016Safety, 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 PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.NULLActive, not recruiting4 Years17 YearsAll91Phase 3Belgium;Germany;Italy;United Kingdom
29NCT03406286
(ClinicalTrials.gov)
July 19, 201622/12/2017Samsca PMS in ADPKD PatientsPost-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKDSafetyDrug: TolvaptanKorea Otsuka Pharmaceutical Co., Ltd.NULLRecruiting18 YearsN/AAll600Korea, Republic of
30NCT02656017
(ClinicalTrials.gov)
June 27, 201623/12/2015Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney DiseaseMetformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney, Autosomal DominantDrug: Metformin;Other: PlaceboKyongtae Ty Bae, M.D., Ph.D.Tufts Medical Center;University of Maryland, Baltimore;University of Southern California;United States Department of DefenseActive, not recruiting18 Years60 YearsAll97Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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agemax
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Target_
size
PhaseCountries
31NCT02697617
(ClinicalTrials.gov)
January 26, 201630/10/2015Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney DiseaseUse of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic KidneyPolycystic Kidney DiseaseDrug: Pioglitazone;Drug: PlaceboIndiana UniversityNULLActive, not recruiting18 Years55 YearsAll18Phase 2United States
32NCT02616055
(ClinicalTrials.gov)
December 201524/11/2015Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101Long-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 DiseaseAutosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: tesevatinibKadmon Corporation, LLCNULLTerminated18 Years55 YearsAll15Phase 2United States
33NCT03803124
(ClinicalTrials.gov)
December 20157/1/2019Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKDEffect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKDPolycystic Kidney, Autosomal DominantDrug: Tolvaptan;Drug: PlaceboRegional Hospital HolstebroNULLCompleted18 YearsN/AAll20Phase 3Denmark
34NCT02494141
(ClinicalTrials.gov)
November 12, 201525/6/2015Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKDCurcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKDPolycystic Kidney, Autosomal DominantDrug: Curcumin;Other: PlaceboUniversity of Colorado, DenverNULLActive, not recruiting6 Years25 YearsAll68Phase 4United States
35NCT02558595
(ClinicalTrials.gov)
September 22, 201521/9/2015Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney DiseasePolycystic Kidney DiseaseDietary Supplement: Niacinamide;Other: PlaceboUniversity of Kansas Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 Years60 YearsAll36Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
36NCT02776241
(ClinicalTrials.gov)
September 20154/5/2016Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney DiseaseEffect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA StudyADPKDOther: waterRigshospitalet, DenmarkAarhus University HospitalCompleted18 YearsN/AAll40N/ADenmark
37NCT02527863
(ClinicalTrials.gov)
February 201518/2/2015Effect of the Aquaretic Tolvaptan on Nitric Oxide SystemThe 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 DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan;Drug: PlaceboRegional Hospital HolstebroAarhus University HospitalCompleted18 Years65 YearsAll18Phase 2Denmark
38NCT02251275
(ClinicalTrials.gov)
October 17, 201425/9/2014Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseA 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 DiseasePolycystic Kidney, Autosomal DominantDrug: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 YearsN/AAll1803Phase 3United 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
39NCT02134899
(ClinicalTrials.gov)
October 14, 201428/4/2014The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted RecipientsAn 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 DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Everolimus;Drug: Calcineurin inhibitors maintenanceAssistance Publique - Hôpitaux de ParisNovartisCompleted18 Years75 YearsAll3Phase 3France
40NCT02127437
(ClinicalTrials.gov)
September 19, 20142/4/2014Lanreotide In Polycystic Kidney Disease StudyLanreotide In Polycystic Kidney Disease StudyAutosomal Dominant Polycystic Kidney Disease (ADPKDDrug: Lanreotide;Drug: salineAssistance Publique - Hôpitaux de ParisIPSEN pharmaceutical company, Boulogne-Billancourt, FranceCompleted18 YearsN/AAll159Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
41NCT02140814
(ClinicalTrials.gov)
May 201414/5/2014Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney DiseaseUncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney DiseasePolycystic Kidney DiseaseDietary Supplement: NiacinamideAlan Yu, MB, BChirNULLCompleted18 Years50 YearsBoth10Phase 2United States
42NCT02160145
(ClinicalTrials.gov)
May 20146/6/2014Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney DiseaseA 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 DiseaseChronic Kidney Disease;Autosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan (OPC-41061);Drug: PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years65 YearsAll1370Phase 3United 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
43NCT02225860
(ClinicalTrials.gov)
May 201420/8/2014Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney DiseaseLow Osmolar Diet and Adjusted Water Intake for Vasopressin Suppression in ADPKDAutosomal Dominant Polycystic Kidney Disease (ADPKD)Behavioral: Diet and water adjustmentTufts Medical CenterNULLCompleted18 Years60 YearsAll34Phase 2;Phase 3United States
44NCT02055079
(ClinicalTrials.gov)
April 201431/1/2014Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney DiseasePulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease - The Vienna RAP StudyPolycystic Kidney, Type 1 Autosomal Dominant Disease;Polycystic Kidney, Type 2 Autosomal Dominant DiseaseDrug: Sirolimus;Drug: PlaceboMedical University of ViennaNULLUnknown status18 YearsN/AAll68Phase 3Austria
45NCT02847624
(ClinicalTrials.gov)
March 201425/7/2016Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKDPost-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in JapanPolycystic Kidney, Autosomal DominantDrug: tolvaptanOtsuka Pharmaceutical Co., Ltd.NULLRecruitingN/AN/AAll1600Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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PhaseCountries
46NCT01853553
(ClinicalTrials.gov)
July 20138/5/2013Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD)Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic KidneyADPKDDrug: Spironolactone;Drug: Sugar pillUniversity of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed20 Years55 YearsAll61Phase 3United States
47NCT01559363
(ClinicalTrials.gov)
September 20129/3/2012A Safety, Pharmacokinetic and Dose-Escalation Study of KD019 (Tesevatinib) in Subjects With ADPKDA Phase 1b/2a, Safety, Pharmacokinetic and Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic Kidney, Autosomal DominantDrug: KD019 (tesevatinib)Kadmon Corporation, LLCNULLCompleted22 Years62 YearsAll74Phase 1;Phase 2United States
48NCT01670110
(ClinicalTrials.gov)
August 201217/8/2012Pasireotide LAR in Severe Polycystic Liver DiseaseA Randomized, Placebo Controlled Clinical Trial of SOM230 (Pasireotide LAR) In Severe Polycystic Liver DiseaseSomatostatin Analogs;Polycystic Liver Disease;Autosomal Dominant Polycystic Kidney Disease;Autosomal Dominant Polycystic Liver DiseaseDrug: Pasireotide LAR;Drug: PlaceboMayo ClinicNULLCompleted18 Years100 YearsAll48Phase 2United States
49NCT01616927
(ClinicalTrials.gov)
June 20126/6/2012Study of Lanreotide to Treat Polycystic Kidney DiseaseThe DIPAK 1 Study: A Randomised, Controlled Clinical Trial Assessing the Efficacy of Lanreotide to Halt Disease Progression in ADPKDAutosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: LanreotideUniversity Medical Center GroningenLeiden University Medical Center;Erasmus Medical Center;Radboud UniversityActive, not recruiting18 Years60 YearsAll300Phase 3Netherlands
50NCT01451827
(ClinicalTrials.gov)
October 201111/10/20118-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 DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan MR;Drug: Tolvaptan IR;Drug: PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years50 YearsAll178Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT01377246
(ClinicalTrials.gov)
May 201120/6/2011Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal InsufficiencyA 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 INSUFFICIENCYAutosomal Dominant Polycystic Kidney DiseaseDrug: Octreotide-LAR;Other: Saline solution.Mario Negri Institute for Pharmacological ResearchNULLCompleted18 Years75 YearsAll100Phase 3Italy
52EUCTR2011-000138-12-IT
(EUCTR)
04/04/201128/12/2011A 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 2A 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
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
80Phase 3Italy
53EUCTR2010-023017-65-ES
(EUCTR)
18/03/201127/01/2011ESTUDIO 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.NULLNot RecruitingFemale: yes
Male: yes
275Phase 2Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden
54NCT01233869
(ClinicalTrials.gov)
December 201028/10/2010Bosutinib For Autosomal Dominant Polycystic Kidney DiseaseA 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 DominantDrug: Bosutinib;Drug: PlaceboPfizerNULLCompleted18 Years50 YearsAll172Phase 2United States;Australia;Canada;Czech Republic;Hungary;Italy;Korea, Republic of;Lithuania;Moldova, Republic of;Poland;Romania;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom
55NCT01280721
(ClinicalTrials.gov)
November 20106/12/2010A 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: tolvaptanOtsuka Pharmaceutical Co., Ltd.NULLCompleted23 Years53 YearsAll135Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT01210560
(ClinicalTrials.gov)
October 201021/9/2010Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKDA 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 DiseaseDrug: Tolvaptan MR;Drug: Tolvaptan IROtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years50 YearsAll25Phase 2United States
57NCT01336972
(ClinicalTrials.gov)
October 201015/4/2011Short-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 FunctionAutosomal Dominant Polycystic Kidney DiseaseDrug: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years70 YearsAll29Phase 2Netherlands
58NCT01214421
(ClinicalTrials.gov)
May 201026/9/2010Open-Label Tolvaptan Study in Subjects With ADPKDMulti-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: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 YearsN/AAll1083Phase 3United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Romania;Russian Federation;United Kingdom
59EUCTR2009-012376-27-IT
(EUCTR)
16/11/200930/11/2009EFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN IIEFFECTS 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. NEGRINULLNot RecruitingFemale: yes
Male: yes
Italy
60NCT01022424
(ClinicalTrials.gov)
November 200927/11/2009A 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 DiseaseDrug: OPC-41061Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll13Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT00920309
(ClinicalTrials.gov)
June 200912/6/2009Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to TherapyRapamycin as Treatment for ADPKD: The Role of Biomarkers in Predicting a Response to TherapyAutosomal Dominant Polycystic Kidney DiseaseDrug: Rapamycin;Other: Standard of Care-PlaceboYale UniversityNULLTerminated18 Years70 YearsAll21Phase 2;Phase 3United States
62NCT00784030
(ClinicalTrials.gov)
November 200831/10/2008High Water Intake to Slow Progression of Polycystic Kidney DiseaseThe Effect of Water Loading on Urinary BiomarkersKidney, Polycystic, Autosomal DominantOther: WaterNew York University School of MedicineNULLCompleted18 Years65 YearsAll23N/AUnited States
63NCT00426153
(ClinicalTrials.gov)
January 200722/1/2007Octreotide in Severe Polycystic Liver DiseasePilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver DiseasePolycystic Kidney, Autosomal Dominant;Polycystic Liver Disease;Hepatomegaly;Liver Diseases;Kidney, Polycystic;Abdominal PainDrug: Octreotide;Drug: PlaceboMayo ClinicNovartis;National Center for Research Resources (NCRR)Completed18 Years80 YearsAll42Phase 2;Phase 3United States
64NCT00428948
(ClinicalTrials.gov)
January 200726/1/2007Tolvaptan 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 DiseasePolycystic Kidney Disease, Autosomal DominantDrug: Tolvaptan;Drug: PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.Otsuka Pharmaceutical Co., Ltd.Completed18 Years50 YearsAll1445Phase 3United States;Argentina;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Netherlands;Poland;Romania;Russian Federation;United Kingdom
65NCT00414440
(ClinicalTrials.gov)
December 200620/12/2006Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney DiseaseA 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 DiseaseDrug: Placebo;Drug: EverolimusNovartis PharmaceuticalsNULLCompleted18 Years50 YearsAll431Phase 4Austria;France;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT00456365
(ClinicalTrials.gov)
November 200612/3/2007Effect 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 DiseasePolycystic Kidney, Autosomal DominantDrug: pravastatin;Drug: PlaceboUniversity of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed8 Years22 YearsAll110Phase 3United States
67NCT00286156
(ClinicalTrials.gov)
October 20061/2/2006Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney DiseasesDrug: RapamuneThe Cleveland ClinicWyeth is now a wholly owned subsidiary of PfizerCompleted18 Years75 YearsAll30Phase 1;Phase 2United States
68NCT00841568
(ClinicalTrials.gov)
April 20069/2/2009A 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 DiseaseDrug: OPC-41061Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll17Phase 2Japan
69EUCTR2005-005552-41-IT
(EUCTR)
20/02/200606/03/2007Effect of long-acting somatostatin on disease progression in nephropathy due to autosomal dominant polycystic disease a long-term three year follow-up study - ALADINEffect 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
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
66Phase 3Italy
70NCT00283686
(ClinicalTrials.gov)
January 200626/1/2006HALT Progression of Polycystic Kidney Disease Study AHALT Progression of Polycystic Kidney Disease Study AKidney, PolycysticDrug: Lisinopril;Drug: Telmisartan;Drug: Placebo;Other: Standard Blood Pressure Control;Other: Low Blood Pressure ControlNational 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 MedicineCompleted15 Years64 YearsAll558Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT01885559
(ClinicalTrials.gov)
January 200617/6/2013HALT Progression of Polycystic Kidney Disease Study BHALT Progression of Polycystic Kidney Disease Study BKidney, PolycysticDrug: Lisinopril;Drug: Telmisartan;Drug: PlaceboNational 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 MedicineCompleted15 Years64 YearsAll486Phase 3United States
72NCT00413777
(ClinicalTrials.gov)
December 200518/12/2006Tolvaptan 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 DiseasePolycystic Kidney, Autosomal DominantDrug: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.Otsuka Pharmaceutical Co., Ltd.Completed18 YearsN/AAll46Phase 2United States