67. 多発性嚢胞腎 Polycystic kidney disease Clinical trials / Disease details


臨床試験数 : 216 薬物数 : 219 - (DrugBank : 50) / 標的遺伝子数 : 39 - 標的パスウェイ数 : 151

  
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT04939935
(ClinicalTrials.gov)
April 202216/6/2021Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD): A Randomised Placebo-Controlled TrialAutosomal Dominant Polycystic Kidney DiseaseDrug: Metformin XR;Other: ControlThe University of QueenslandNULLNot yet recruiting18 Years70 YearsAll1164Phase 3Australia
2EUCTR2021-003062-12-SK
(EUCTR)
11/03/202216/11/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1350Phase 3Portugal;Belarus;Serbia;United States;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Australia;Denmark;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand
3NCT05190744
(ClinicalTrials.gov)
March 1, 202229/12/2021PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium AdministrationA Multi-center, Open-Label, Exploratory Study to Assess the Efficacy of PB in Decreasing the Urine Output and Increasing the Urine Osmolality in Patients With Hereditary Nephrogenic Diabetes Insipidus, Patients With Autosomal Dominant Polycystic Kidney Disease Treated With Tolvaptan, And Severely Polyuric Patients With Previous Lithium Administration (Serendipity-PB1)Autosomal Dominant Polycystic Kidney Disease;Nephrogenic Diabetes Insipidus;Acquired Nephrogenic Diabetes Insipidus;Congenital Nephrogenic Diabetes InsipidusDrug: PBMayo ClinicHopital du Sacre-Coeur de MontrealRecruiting18 YearsN/AAll20Phase 2United States
4NCT05208866
(ClinicalTrials.gov)
February 10, 20227/1/2022Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303PA-ADPKD-304: A Phase 3, Open-label, Roll-over Study to Assess Long-term Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Who Completed Study PA-ADPKD-303: The ALERT StudyPolycystic Kidney Disease, AdultDrug: LixivaptanPalladio BiosciencesNULLEnrolling by invitation18 YearsN/AAll12Phase 3United States
5EUCTR2021-003062-12-BG
(EUCTR)
09/02/202206/12/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Israel;Chile;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia
6EUCTR2021-003062-12-ES
(EUCTR)
21/01/202220/10/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia
7EUCTR2021-003062-12-IT
(EUCTR)
20/01/202218/10/2021A clinical trial to look at how safe and how effective Lixivaptan in patients with kidney disease compared to a placebo treatment.A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: [0C23]
INN or Proposed INN: Lixivaptan
Palladio Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia
8EUCTR2021-002551-11-DK
(EUCTR)
18/01/202227/05/2021Chronic kidney disease – imaging the metabolic derangements with ultra-sensitive MRIChronic kidney disease – imaging the metabolic derangements with ultra-sensitive MRI Chronic kidney disease and polycystic kidney disease
MedDRA version: 23.1;Level: PT;Classification code 10064848;Term: Chronic kidney disease;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Product Name: Hyperpolarized [1-13C]pyruvate
INN or Proposed INN: SODIUM PYRUVATE
Other descriptive name: SODIUM PYRUVATE
Aarhus UniversityNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Denmark
9EUCTR2021-003062-12-HU
(EUCTR)
03/01/202205/11/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia
10EUCTR2020-000433-40-NL
(EUCTR)
30/12/202103/08/2021Treatment of stiffness in blood vessels in patients with familial cystic kidney diseaseTreatment of vascular stiffness in patients with autosomal dominant polycystic kidney disease - TRAMPOLINE Autosomal dominant polycystic kidney disease;Therapeutic area: Not possible to specifyTrade Name: Amiloride
Product Name: Amiloride
INN or Proposed INN: AMILORIDE
Trade Name: Sodium Chloride
INN or Proposed INN: Sodium chloride
Other descriptive name: Sodium Chloride
Erasmus University Medical Centre RotterdamNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 4Netherlands
11NCT04064346
(ClinicalTrials.gov)
October 28, 202119/8/2019Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney DiseaseA 2-Year, Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-label PhasePolycystic Kidney Disease, AdultDrug: Lixivaptan;Drug: PlaceboPalladio BiosciencesNULLRecruiting18 Years60 YearsAll1200Phase 3United States;Argentina;Australia;Canada;Chile;Hungary;Israel;Romania;Spain
12EUCTR2020-005949-16-NL
(EUCTR)
25/10/202121/10/2021A study into the efficacy and toleratability of leuprorelin by patients suffering from severe polycystic liver diseaseA GnRH Agonist IN pre-menopausal women STudy to treat severe Polycystic Liver Disease - AGAINST-PLD Severe polycystic liver disease in female patients
MedDRA version: 20.1;Level: PT;Classification code 10048834;Term: Polycystic liver disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10036045;Term: Polycystic kidney;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Classification code 10083939;Term: Autosomal dominant polycystic liver disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Lucrin
Product Name: Lucrin
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
36Phase 2Netherlands
13NCT04908462
(ClinicalTrials.gov)
June 8, 202118/5/2021To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease SubjectsA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease Subjects Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211Autosomal Dominant Polycystic KidneyDrug: AL01211 or Placebo (Part A);Drug: AL01211 or Placebo (Part B);Drug: AL01211 or Placebo (Part C)AceLink Therapeutics, Inc.Novotech (Australia) Pty LimitedRecruiting18 Years55 YearsAll98Phase 1Australia
14EUCTR2020-004400-34-NL
(EUCTR)
12/05/202104/02/2021Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustatMulticenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT Congenital cystic kidney disease
MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: venglustat malate
Other descriptive name: GZ/SAR402671
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
640Phase 3Portugal;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of
15EUCTR2020-004400-34-BE
(EUCTR)
11/05/202118/02/2021Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustatMulticenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT Congenital cystic kidney disease
MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: venglustat malate
Other descriptive name: GZ/SAR402671
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
640Phase 3Portugal;Czechia;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of
16EUCTR2020-004400-34-PT
(EUCTR)
30/04/202105/03/2021Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustatMulticenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT Congenital cystic kidney disease
MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: venglustat malate
Other descriptive name: GZ/SAR402671
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
640Phase 3Portugal;Czechia;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of
17EUCTR2020-004400-34-IT
(EUCTR)
14/04/202108/06/2021Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustatMulticenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT Congenital cystic kidney disease
MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Venglustat
Product Code: [SAR402671, GZ402671 o GZ/SAR402671]
INN or Proposed INN: venglustat malato
Other descriptive name: GZ/SAR402671
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
640Phase 3Portugal;Czechia;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of
18NCT04786574
(ClinicalTrials.gov)
April 1, 202119/2/2021A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 12 Weeks of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)Autosomal Recessive Polycystic Kidney Disease (ARPKD)Drug: Tolvaptan (OPC-41061)Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot yet recruitingN/A12 WeeksAll20Phase 3NULL
19NCT04782258
(ClinicalTrials.gov)
April 1, 202119/2/2021A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)Autosomal Recessive Polycystic Kidney (ARPKD)Drug: Tolvaptan Suspension;Drug: Tolvaptan TabletsOtsuka Pharmaceutical Development & Commercialization, Inc.NULLNot yet recruitingN/A18 YearsAll20Phase 3NULL
20EUCTR2020-004400-34-DE
(EUCTR)
23/03/202125/02/2021Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustatMulticenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT Congenital cystic kidney disease
MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: venglustat malate
Other descriptive name: GZ/SAR402671
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
640Phase 3Portugal;Czechia;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Korea, Republic of
21NCT04705051
(ClinicalTrials.gov)
February 9, 20218/1/2021Multicenter, Open-label, Extension Study to Characterize the Long-term Efficacy and Safety of Early Versus Delayed Treatment With Venglustat (GZ/SAR402671) in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)Multicenter, Open-label, Extension Study to Characterize the Long-term Efficacy and Safety of Early Versus Delayed Treatment With Venglustat (GZ/SAR402671) in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)Congenital Cystic Kidney DiseaseDrug: Venglustat GZ402671SanofiNULLTerminated18 YearsN/AAll24Phase 3United States;Australia;Belgium;France;Germany;Japan;Korea, Republic of;Netherlands;Romania;Spain
22JPRN-jRCT2031200348
09/02/202105/02/2021Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustatMulticenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT Congenital cystic kidney diseaseDrug: Venglustat (GZ402671)
Pharmaceutical form: capsule, Route of administration: oral
Tanaka TomoyukiNULLSuspended>= 18age oldNot applicableBoth640Phase 3United States;Japan
23NCT04680780
(ClinicalTrials.gov)
January 10, 20211/10/2020Ketogenic Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease (ADPKD)Ketogenic Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease (ADPKD)ADPKDOther: Ketogenic diet;Other: 3-days water-fasting;Other: ControlUniversity of CologneNULLActive, not recruiting18 Years60 YearsAll63N/AGermany
24NCT04578548
(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, Followed by an Open-label Extension Period of 52 Weeks in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Placebo;Drug: GLPG2737Galapagos NVNULLActive, not recruiting18 Years50 YearsAll66Phase 2Spain;Poland;Netherlands;Italy;Germany;Czechia;Belgium
25NCT04407481
(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
26EUCTR2019-003521-21-CZ
(EUCTR)
14/10/202028/07/2020A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenterstudy to evaluate the efficacy, safety, tolerability and pharmacokinetics oforally administered GLPG2737 for 52 weeks, followed by an open-labelextension period of 52 weeks in subjects with autosomal dominantpolycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Germany;Netherlands;Italy
27NCT04536688
(ClinicalTrials.gov)
October 13, 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.NULLCompleted18 Years70 YearsAll19Phase 1United States
28EUCTR2019-003521-21-DE
(EUCTR)
14/09/202010/03/2020A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Netherlands;Germany;Italy
29NCT04310319
(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
30NCT04152837
(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
31EUCTR2019-003521-21-IT
(EUCTR)
22/07/202011/01/2021A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, in subjects with autosomal dominant polycystic kidney disease - A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney di Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: [G1117337]
Other descriptive name: GLPG2737
GALAPAGOS NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Italy;United Kingdom;Germany;Netherlands;Bulgaria;Ireland;Belgium;Greece;Czech Republic
32EUCTR2019-003521-21-NL
(EUCTR)
18/03/202007/11/2019A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Germany;Netherlands;Italy
33EUCTR2018-004651-20-GB
(EUCTR)
13/02/202007/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 10 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 20 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 15 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;France;Czech Republic;Spain;Belgium;Australia;Germany;Italy;United Kingdom
34EUCTR2019-003521-21-BE
(EUCTR)
20/01/202024/10/2019A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Germany;Netherlands;Italy
35EUCTR2018-004651-20-DE
(EUCTR)
20/01/202007/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 10 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 20 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 15 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
850Phase 3France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy;Japan
36EUCTR2018-004651-20-CZ
(EUCTR)
12/12/201923/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 10 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 20 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 15 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy;Japan
37EUCTR2018-004651-20-IT
(EUCTR)
20/11/201905/01/2021A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: [RTA 402]
INN or Proposed INN: Bardoxolone Metile
Other descriptive name: Bardoxolone methyl
Product Name: Bardoxolone methyl 10 mg
Product Code: [RTA 402]
INN or Proposed INN: bardoxolone methyl
Other descriptive name: bardoxolone methyl
Product Name: Bardoxolone methyl 20 mg
Product Code: [RTA 402]
INN or Proposed INN: Bardoxolone methyl
Other descriptive name: Bardoxolone methyl
Product Name: Bardoxolone methyl 15 mg
Product Code: [RTA 402]
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: Bardoxolone methyl
REATA PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy
38EUCTR2018-004651-20-ES
(EUCTR)
19/11/201904/09/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 10 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 20 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 15 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Belgium;Spain;Australia;Germany;Italy;United Kingdom
39EUCTR2018-004651-20-BE
(EUCTR)
14/10/201929/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 10 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 20 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 15 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Japan;Italy
40NCT03949894
(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
41NCT03918447
(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 YearsAll550Phase 3United States;Australia;Belgium;Czechia;France;Germany;Italy;Japan;Spain;United Kingdom
42EUCTR2017-004084-12-AT
(EUCTR)
11/04/201914/01/2019A 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) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Japan;Korea, Republic of
43JPRN-jRCTs031180259
01/04/201914/03/2019Tolvaptan Intervention study and Genetic mutation of AutosomalDominant Polycystic Kidney DiseaseTolvaptan Intervention study to Autosomal Dominant PolycysticKidney Disease patients without Genetic mutation of disease gene - TIAG ADPKDTolvaptan treatmentHorie ShigeoNULLComplete>= 20age oldNot applicableBoth10N/AJapan
44JPRN-UMIN000039943
2019/03/0825/03/2020An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney DiseaseAn Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease - A Trial of Bardoxolone Methyl in Patients with Chronic Kidney Disease - EAGLE Chronic Kidney DiseaseAlport SyndromeAutosomal Dominant Polycystic KidneyBardoxolone methylReata Pharmaceuticals, Inc.Kyowa Kirin Co., Ltd.RecruitingNot applicableNot applicableMale and Female480Phase 3Japan,North America,Australia,Europe
45NCT03749447
(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;Puerto Rico;Japan;Australia
46NCT03717181
(ClinicalTrials.gov)
February 19, 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 BiosciencesNULLNo longer available15 Years60 YearsAllUnited States
47EUCTR2017-004084-12-NL
(EUCTR)
13/02/201906/06/2018A 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) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
48JPRN-JapicCTI-184192
31/1/201905/11/2018A 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 dominantIntervention 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.NULLother1855BOTH640Phase 2-3Japan, Asia except Japan, North America, South America, Europe, Oceania
49NCT03764605
(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
50NCT04284657
(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 CaliforniaNULLEnrolling by invitation18 YearsN/AAll30Phase 2United States
51EUCTR2017-004084-12-GB
(EUCTR)
28/01/201924/05/2018A 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) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
52NCT03541447
(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.Completed18 YearsN/AAll20Phase 2Italy
53EUCTR2018-000477-77-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
54EUCTR2017-004084-12-DK
(EUCTR)
07/11/201823/05/2018A 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) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2Portugal;United States;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of
55NCT03687554
(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
56NCT03523728
(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 CompanyNULLTerminated18 Years55 YearsAll478Phase 2/Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Germany;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Spain;Taiwan;Turkey;United Kingdom
57NCT03487913
(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
58NCT03596957
(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
59EUCTR2017-004084-12-BE
(EUCTR)
31/08/201831/05/2018A 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) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Japan;Korea, Republic of
60EUCTR2017-004084-12-PT
(EUCTR)
06/08/201811/06/2018A 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) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2Portugal;United States;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
61EUCTR2017-004701-40-IT
(EUCTR)
06/08/201826/09/2019 STUDY TO ASSESS THE SHORT-TERM EFFECT OF THE ADMINISTRATION OF TOLVAPTAN AND OCTREOTIDE LAR COMPARED TO THE COMBINATION OF TOLVAPTAN AND PLACEBO IN PATIENTS AFFECTED BY ADPKD WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE LAR COMBINATION THERAPY IN ADPKD PATIENTS WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION - Tolvaptan-Octreotide combination in ADPKD Autosomal Dominant Policiytic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG)
Product Name: Jinarc
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG)
Product Name: Jinarc
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 30 MG +90 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 90 MG)
Product Name: Jinarc
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: SANDOSTATINA - LAR 20 MG/2.5 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE FLACONE POLVERE + SIRINGA PRERIEMPITA 2.5 ML + 2 AGHI
Product Name: sandostatina LAR
Product Code: sandostatina
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRINULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly
62EUCTR2017-004084-12-IT
(EUCTR)
12/07/201817/06/2021Study of Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - SAVE-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
GENZYME CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
982Phase 2Portugal;United States;Czechia;Taiwan;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
63EUCTR2017-004084-12-DE
(EUCTR)
10/07/201822/05/2018A Medical Research Study Designed to Determine if Venglustat can be aFuture 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) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Japan;Korea, Republic of
64EUCTR2017-004084-12-CZ
(EUCTR)
03/07/201813/06/2018A 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) - STAGED-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
982Phase 2United States;Portugal;Czechia;Taiwan;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
65EUCTR2017-004084-12-ES
(EUCTR)
05/06/201806/06/2018Study of Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - SAVE-PKD Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: Venglustat
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
836 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Spain;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
66EUCTR2017-003864-10-NL
(EUCTR)
02/05/201808/03/2018Medication for excessive urine production in patients treated with tolvaptanHydrochlorothiazide and metformin cross-over study for attenuating aquaretic side-effects in ADPKD patients treated with tolvaptan Autosomal dominant polycystic kidney disease;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Product Name: Hydrochlorothiazide
Product Code: HCT
Product Name: Metformin
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2Netherlands
67NCT03423810
(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
68EUCTR2017-004115-39-DK
(EUCTR)
08/02/201813/12/2017Same as aboveSubacute Effect of Tolvaptan on Total Kidney Volumen in Adult Patients with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney DIsease
MedDRA version: 20.0;Level: LLT;Classification code 10036045;Term: Polycystic kidney;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Jinarc 15 mg tablets, Jinarc 45 mg tablets
Product Name: Jinarc - Tolvaptan tablets
Product Code: 15 or 45 mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Trade Name: Jinarc 30 mg tablets, Jinarc 60 mg tablets
Product Name: Jinarc - Tolvaptan tablets
Product Code: 30 or 60 mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Trade Name: Jinarc 30 mg tablets, 90 mg tablets
Product Name: Jinarc - Tolvaptan tablets
Product Code: 30 or 90 mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Nordsjællands Hospital, Department of Cardiology, Nephrology and EndocrinologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 4Denmark
69NCT03366337
(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
70NCT03273413
(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
71NCT03203642
(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, LLCNULLCompleted18 Years60 YearsAll80Phase 2United States
72NCT03096080
(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
73NCT03102632
(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 UniversityActive, not recruiting18 Years65 YearsAll10N/AUnited States
74NCT02903511
(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 YearsAll56Phase 2United States
75EUCTR2016-000187-42-GB
(EUCTR)
24/10/201606/05/2016A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Tolvaptan 7.5 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 30 Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3Belgium;Germany;Italy;United Kingdom
76EUCTR2016-000187-42-DE
(EUCTR)
13/10/201610/05/2016A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Tolvaptan 7.5 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 30 Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3Belgium;Germany;United Kingdom;Italy
77NCT02729662
(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
78NCT02933268
(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
79EUCTR2016-000187-42-IT
(EUCTR)
26/09/201612/05/2016A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Tolvaptan 7.5 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 30 Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3Hungary;Poland;Belgium;Spain;Germany;United Kingdom;Italy
80NCT02964273
(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: Phase A Tolvaptan;Drug: Placebo Phase A;Drug: Phase B TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted4 Years17 YearsAll91Phase 3Belgium;Germany;Italy;United Kingdom
81EUCTR2016-000187-42-BE
(EUCTR)
24/08/201624/05/2016A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Tolvaptan 7.5 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 30 Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3Belgium;Germany;United Kingdom;Italy
82NCT03406286
(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
83NCT02656017
(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 DefenseCompleted18 Years60 YearsAll97Phase 2United States
84EUCTR2014-001516-19-DK
(EUCTR)
15/06/201614/04/2016 This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization,NULLNot Recruiting Female: yes
Male: yes
2500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Australia;South Africa;Norway;Netherlands;Germany;Sweden
85EUCTR2014-001516-19-HU
(EUCTR)
02/05/201601/03/2016This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization,NULLNot RecruitingFemale: yes
Male: yes
2500Phase 3United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Australia;South Africa;Norway;Netherlands;Germany;Sweden
86EUCTR2014-001516-19-CZ
(EUCTR)
06/04/201628/01/2016This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization,NULLNot RecruitingFemale: yes
Male: yes
2500Phase 3United States;Spain;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;South Africa;Norway;Germany;Netherlands;Sweden
87EUCTR2014-001516-19-SE
(EUCTR)
04/02/201605/11/2014This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization,NULLNot RecruitingFemale: yes
Male: yes
2500Phase 3United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;South Africa;Norway;Netherlands;Germany;Sweden
88NCT02697617
(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
89EUCTR2014-001501-41-BE
(EUCTR)
16/01/201617/12/2015A 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 specifyTrade Name: Jinarc
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3France;United States;Argentina;Belgium;Germany;Japan
90EUCTR2014-001501-41-FR
(EUCTR)
30/12/201515/01/2016A 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 specifyTrade Name: Jinarc
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;France;Argentina;Belgium;Germany;Japan
91NCT02616055
(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
92NCT03803124
(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
93NCT02494141
(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, DenverNULLCompleted6 Years25 YearsAll68Phase 4United States
94EUCTR2014-001516-19-ES
(EUCTR)
30/10/201511/09/2015This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization,NULLNot RecruitingFemale: yes
Male: yes
2500Phase 3United States;Spain;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Australia;Peru;South Africa;Netherlands;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden
95EUCTR2014-000226-38-FR
(EUCTR)
16/10/201511/12/2015This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic 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 EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Spain;Taiwan;United States
96NCT02558595
(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
97NCT02776241
(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
98EUCTR2015-001903-30-DK
(EUCTR)
26/06/201513/05/2015Effect of tolvaptan on renal blood flow and glomerular filtration in patients with polycystic kidney diseaseEffect of tolvaptan on RBF and GFR in ADPKD - Tolvaptan and RPF in ADPKD Adult dominant polycystic kidney disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Physical Phenomena [G01]
Trade Name: Samsca
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Denmark
99EUCTR2014-001516-19-PL
(EUCTR)
27/05/201519/02/2015 This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization,NULLNot Recruiting Female: yes
Male: yes
2500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Australia;South Africa;Norway;Netherlands;Germany;Sweden
100EUCTR2014-001516-19-FR
(EUCTR)
30/03/201507/01/2015This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2500Phase 3United States;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;South Africa;Netherlands;United Kingdom;Czech Republic;Hungary;Mexico;Sweden;Norway;Germany;Romania;Poland;Belgium;Brazil;Argentina;Canada
101EUCTR2014-001516-19-GB
(EUCTR)
26/03/201530/09/2014 This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease - Otsuka_156-13-211 Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization,NULLNot Recruiting Female: yes
Male: yes
2500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited 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
102EUCTR2014-000226-38-PL
(EUCTR)
10/03/201508/12/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic 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 EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Norway;Germany;Sweden
103EUCTR2014-001516-19-NL
(EUCTR)
09/03/201506/11/2014 This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease. A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization,NULLNot Recruiting Female: yes
Male: yes
2500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGermany;Norway;Sweden;Romania;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Netherlands;South Africa;Peru;Denmark;Australia;France;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Spain;United States
104EUCTR2014-001516-19-BE
(EUCTR)
11/02/201517/11/2014 This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization,NULLNot Recruiting Female: yes
Male: yes
2500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited 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
105NCT02527863
(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
106EUCTR2014-000226-38-CZ
(EUCTR)
21/01/201513/11/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic 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 EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
107EUCTR2014-000226-38-GB
(EUCTR)
08/01/201531/07/2014 This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot Recruiting Female: yes
Male: yes
1300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
108EUCTR2014-000226-38-ES
(EUCTR)
02/01/201516/10/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic 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 Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
109EUCTR2014-000226-38-NL
(EUCTR)
22/12/201424/09/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic 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 Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
110EUCTR2014-000226-38-BE
(EUCTR)
17/12/201426/09/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic 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 EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
111EUCTR2014-001516-19-IT
(EUCTR)
10/12/201416/10/2014A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization,NULLNot RecruitingFemale: yes
Male: yes
2500Phase 3United States;Spain;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Australia;Peru;South Africa;Netherlands;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden
112EUCTR2014-000226-38-DK
(EUCTR)
02/12/201411/09/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic 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 EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
113EUCTR2014-000226-38-SE
(EUCTR)
21/11/201414/08/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic 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 EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
114JPRN-UMIN000015715
2014/11/2025/11/2014Clinical Efficacy Study of Tolvaptan on Patients with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney DiseaseTolvaptan administrationKyorin University School of MedicineNULLComplete: follow-up complete18years-oldNot applicableMale and Female100Phase 4Japan
115EUCTR2014-001973-15-DK
(EUCTR)
18/11/201427/06/2014The 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 diseaseRenal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease.The effects of tolvaptan on renal handling of water and sodium , vasoactive hormones and central hemodynamics during baseline conditions and after inhibition of the nitric oxide system in patients with autosomal dominant polycystic kidney disease - TOPO HyponatreamiaSIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) OverhydrationAutosomal dominant polycystic kidney disease
MedDRA version: 17.0;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 100000004861
MedDRA version: 17.0;Classification code 10040626;Term: SIADH;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: C03XA01
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
University Clinic in Nephrology and Hypertension, Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
Denmark
116EUCTR2014-000226-38-IT
(EUCTR)
11/11/201405/08/2014A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden
117EUCTR2014-000226-38-HU
(EUCTR)
03/11/201421/08/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic 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 EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
118NCT02251275
(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
119NCT02134899
(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
120JPRN-UMIN000015245
2014/09/2525/09/2014Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment.Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment. - ADPKD confirmatory study to establish the determinants of disease progression and response to tolvaptan treatment. autosomal dominant polycystic kidney disease (ADPKD)tolvaptan 60~120mg/day
tolvaptan less than 60mg/day
(in case of minimize dose recommended, for example; kidney dysfunction)

tolvaptan less than 60mg/day
(in case of minimize dose recommended, for example; kidney dysfunction)

no medication
tolvaptan less than 60mg/day of start dose
(in case of minimize start dose recommended, for example; less than 20 years old or more than 65 years old)
Department of Nephrology, Tokyo Women's Medical UniversityNULLComplete: follow-up complete15years-oldNot applicableMale and Female100Not applicableJapan
121NCT02127437
(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
122JPRN-UMIN000012865
2014/06/3001/03/2014Ursodeoxycholic acid for polycystic liver diseaseUrsodeoxycholic acid for polycystic liver disease - UDCA for PLD polycystic liver disease, polycystic kidney diseaseUDCA 600mg/day
standard treatment
Nephrology Center, Toranomon HospitalNULLRecruitingNot applicableNot applicableMale and Female100Not selectedJapan
123NCT02160145
(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
124NCT02225860
(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
125NCT02140814
(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
126NCT02055079
(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
127NCT02115659
(ClinicalTrials.gov)
April 201414/4/2014Triptolide-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: PlaceboShanghai Changzheng HospitalNULLRecruiting40 Years75 YearsBoth100Phase 3China
128NCT02166489
(ClinicalTrials.gov)
March 201414/6/2014Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney DiseaseEvaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney DiseaseChronic Renal Failure;Polycystic Kidney DiseaseBiological: Intravenous injection autologous mesenchymal stem cellsRoyan InstituteNULLCompleted18 Years60 YearsBoth6Phase 1Iran, Islamic Republic of
129NCT02847624
(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
130EUCTR2012-000550-60-AT
(EUCTR)
17/01/201427/11/2013Pulsed oral sirolimus in autosomal dominant polycystic kidney diseasePulsed oral sirolimus in autosomal dominant polycystic kidney disease - The Vienna RAP Study Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disorder characterized by the development and uncontrolled proliferation of innumerable epithelial-lined cysts that stem from renal tubular cells, which compress and/or destroy vital renal tissue with a gradual decline in renal function, and terminal kidney failure with the need for renal reaplacement therapy. As yet, other than supportive care there is no viable therapy.
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Rapamune 1mg tablets
Product Name: Rapamune 1mg tablets
INN or Proposed INN: SIROLIMUS
Medizinische Universität Wien, Klinische Abteilung für Nephrologie und Dialyse, Universitätsklinik für Innere Medizin 3NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
68Phase 3Austria
131NCT02021110
(ClinicalTrials.gov)
December 201312/12/2013Ursodeoxycholic Acid as Treatment for Polycystic Liver DiseaseAn International, Multicenter, Randomized Controlled Clinical Trial Assessing the Efficacy of Ursodeoxycholic Acid as a Volume Reducing Treatment in Symptomatic Polycystic Liver DiseasePolycystic Liver Disease;Polycystic Kidney, Autosomal DominantDrug: Ursodeoxycholic AcidRadboud UniversityAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Completed18 Years80 YearsAll34Phase 2Netherlands;Spain
132EUCTR2013-003207-19-NL
(EUCTR)
29/11/201308/08/2013Trial to investigate the effect of ursodeoxycholic acid as a treatment of symptoms in polycystic liver disease: the CURSOR-trialAn international, multicenter, randomized controlled clinical trial assessing the efficacy of Ursodeoxycholic acid as a volume reducing treatment for symptomatic polycystic livers - The CURSOR trial Patients suffering from symptomatic polycystic liver disease (PLD) with underlying diagnosis of isolated polycystic liver disease (PCLD) or autosomal dominant kidney disease (ADPKD);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: URSOCHOL 300Radboud University Nijmegen Medical CenterNULLNot RecruitingFemale: yes
Male: yes
34Phase 4Spain;Netherlands
133NCT01932450
(ClinicalTrials.gov)
August 201318/8/2013Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression ControlA 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 DiseaseAutosomal Dominant Polycystic Kidney Disease;HypertensionProcedure: renal sympathetic denervation;Drug: antihypertensive drugsMei changlinNULLRecruiting20 Years60 YearsBoth100Phase 2China
134NCT01853553
(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
135NCT01559363
(ClinicalTrials.gov)
September 20129/3/2012A Safety, Pharmacokinetic & Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney DiseaseA Phase 1b/2a, Safety, Pharmacokinetic and Dose-Escalation Study of KD019 ((Tesevatinib) in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic Kidney, Autosomal DominantDrug: KD019 (tesevatinib)Kadmon Corporation, LLCNULLCompleted22 Years62 YearsAll74Phase 1/Phase 2United States
136NCT01670110
(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
137NCT01616927
(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
138EUCTR2011-005017-37-NL
(EUCTR)
30/05/201221/05/2012To investigate the effect of Lanreotide on renal function decline in ADPKD patientsA randomised, controlled clinical trial assessing the efficacy ofLanreotide to halt disease progression in ADPKD - The DIPAK 1 Study First, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measuredby change in rate of renal function decline and change in renal volume. Second, to demonstrate whether Lanreotidemodifies progression of the liver phenotype in the subset of ADPKD patients with moderate to severe polycystic liverdisease as measured by change in liver volume.
MedDRA version: 14.1;Level: LLT;Classification code 10023433;Term: Kidney polycystic;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Somatuline Autogel
Product Name: Lanreotide
Product Code: BIM 23014
INN or Proposed INN: Lanreotide
Other descriptive name: LANREOTIDE ACETATE
DIPAK ConsortiumNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
139EUCTR2010-023017-65-BG
(EUCTR)
14/05/201222/05/2012A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with 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) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden
140EUCTR2010-023017-65-LT
(EUCTR)
14/11/201102/09/2011A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275Phase 2Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden
141EUCTR2010-023017-65-IT
(EUCTR)
28/10/201114/03/2012A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness and pharmacokinetics of bosutinib versus placebo in subjects with 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). Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: BOSUTINIB
Other descriptive name: SKI-606
PFIZER INC.NULLNot RecruitingFemale: yes
Male: yes
275Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Australia;Japan;Sweden
142NCT01451827
(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
143NCT01680250
(ClinicalTrials.gov)
September 201130/8/2012Sirolimus for Massive Polycystic LiverAn Open-label, Prospective Clinical Trial to Evaluate the Effectiveness and Safety of Sirolimus to Reduce Cyst Growth in ADPKD Patients With Massive Polycystic LiverPolycystic Kidney DiseasesDrug: SirolimusSeoul National University HospitalWyeth is now a wholly owned subsidiary of PfizerRecruiting18 Years65 YearsBoth44Phase 2/Phase 3Korea, Republic of
144EUCTR2010-023017-65-GB
(EUCTR)
02/08/201108/04/2011A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with 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) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
275 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Germany;Japan;Sweden
145EUCTR2010-023017-65-CZ
(EUCTR)
16/06/201101/02/2011A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with 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) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
190Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Japan;Moldova, Republic of;Sweden
146EUCTR2010-023017-65-HU
(EUCTR)
27/05/201105/04/2011A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with 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) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
190Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Germany;Japan;Moldova, Republic of;Sweden
147EUCTR2010-023017-65-SK
(EUCTR)
25/05/201128/04/2011A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with 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) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
190Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden
148NCT01354405
(ClinicalTrials.gov)
May 201113/5/2011Somatostatin 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 DiseasePolycystic Liver DiseaseDrug: LanreotideRadboud UniversityIpsenCompleted18 Years70 YearsBoth43N/ANetherlands
149NCT01377246
(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
150EUCTR2010-023017-65-PL
(EUCTR)
21/04/201112/04/2011A multicenter, randomized, double-blind, placebo-controlled study of thesafety, effectiveness, and pharmacokinetics of bosutinib versus placebo insubjects with 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) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275Phase 2Hungary;Czech Republic;Slovakia;Spain;Poland;Lithuania;Italy;United Kingdom;Sweden
151EUCTR2011-000138-12-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
Trade Name: SANDOSTATINA LAR
INN or Proposed INN: Octreotide
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
80 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noItaly
152ChiCTR-TRC-11001282
2011-04-012011-04-21Triptolide Retards Autosomal Dominant Polycystic Kidney Disease with ProteinuriaTriptolide Retards Autosomal Dominant Polycystic Kidney Disease with Proteinuria Autosomal dominant polycystic kidney disease;Q61.301Group A:Glucosidorum Tripterygll Totorum+losartan potassium ;Group B:Placebo + losartan potassium;Shanghai Changzheng HospitalNULLCompleted1855BothGroup A:30;Group B:30;China
153EUCTR2009-017849-57-NL
(EUCTR)
24/03/201113/01/2010Somatostatin analogues as a volume reducing treatment of polycystic livers - SOLVESomatostatin analogues as a volume reducing treatment of polycystic livers - SOLVE Polycystic liver disease, due to isolated polycystic liver disease or polycystic kidney disease.
MedDRA version: 12.1;Level: LLT;Classification code 10048834;Term: Polycystic liver disease
MedDRA version: 12.1;Level: PT;Classification code 10036045;Term: Polycystic kidney
MedDRA version: 12.1;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
MedDRA version: 12.1;Classification code 10036048;Term: Polycystic kidney, unspecified type
Product Name: Sandostatin LAR
Product Code: unknown
Product Name: Somatuline Autosolution
Product Code: unknown
Radboud University Nijmegen Medical CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
154EUCTR2010-023017-65-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
155EUCTR2010-023017-65-SE
(EUCTR)
17/03/201120/01/2011A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with 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) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
190Phase 2United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden
156EUCTR2010-018401-10-NL
(EUCTR)
14/01/201121/10/2010A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys.A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
1500France;United States;Canada;Poland;Belgium;Romania;Russian Federation;Afghanistan;Germany;Netherlands;Italy;United Kingdom
157NCT01233869
(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
158EUCTR2010-018401-10-IT
(EUCTR)
24/11/201010/09/2010Multi-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) - NDMulti-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) - ND Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 9.1;Level: LLT;Classification code 10036046
OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INCNULLNot RecruitingFemale: yes
Male: yes
1500France;Netherlands;Germany;United Kingdom;Italy
159EUCTR2010-018401-10-BE
(EUCTR)
23/11/201003/09/2010A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys.A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom
160EUCTR2010-018401-10-FR
(EUCTR)
15/11/201027/07/2010A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;Belgium;Netherlands;Germany;Italy;United Kingdom
161JPRN-JapicCTI-101362
01/11/201003/12/2010A 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.NULL2353BOTH150Phase 3NULL
162NCT01280721
(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
163EUCTR2010-018401-10-GB
(EUCTR)
05/10/201026/08/2010A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys.A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, IncNULLNot Recruiting Female: yes
Male: yes
1500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom
164NCT01336972
(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
165NCT01210560
(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
166NCT01223755
(ClinicalTrials.gov)
September 201012/10/2010Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal InsufficiencyEFFECTS OF SIROLIMUS ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND SEVERE RENAL INSUFFICIENCYAutosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: Sirolimus;Drug: conventional therapyMario Negri Institute for Pharmacological ResearchNULLTerminated18 Years80 YearsBoth41Phase 2/Phase 3Italy
167EUCTR2010-019025-33-NL
(EUCTR)
31/08/201027/07/2010A 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 FunctionA Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
36Phase 2Netherlands
168EUCTR2010-018401-10-DE
(EUCTR)
07/07/201010/06/2010A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys.A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
1500France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom
169NCT01214421
(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
170EUCTR2009-012376-27-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
80Phase 3Italy
171NCT01022424
(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
172NCT01632605
(ClinicalTrials.gov)
November 200913/5/2012The Vienna RAP Pilot StudyRapamycin in Advanced Polycystic Kidney Disease Pilot StudyADPKDDrug: SirolimusMedical University of ViennaNULLCompleted18 YearsN/ABoth8N/AAustria
173NCT00890279
(ClinicalTrials.gov)
July 200928/4/2009Efficacy 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. CCBKidney, Polycystic, Autosomal DominantDrug: Cilnidipine;Drug: ImidaprilMinistry of Health, Labour and Welfare, JapanNULLRecruiting20 Years60 YearsBoth160Phase 2Japan
174NCT00920309
(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
175NCT02119013
(ClinicalTrials.gov)
January 200917/4/2014Effects of Somatostatin on ADPKD HeartEFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A MATCHED-COHORT, SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDYAutosomal Dominant Polycystic Kidney Disease;Glomerular Filtration Rate > 40 ml/MinDrug: Octeotride;Drug: PlaceboFederico II UniversityNULLCompleted18 Years80 YearsBoth35Phase 2/Phase 3NULL
176NCT02119052
(ClinicalTrials.gov)
January 200917/4/2014Effects of Somatostatin on Liver in ADPKDEffect of Long-acting Somatostatin on Liver in Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: octeotride;Drug: placeboFederico II UniversityNULLCompleted18 YearsN/ABoth35Phase 2/Phase 3NULL
177NCT00801268
(ClinicalTrials.gov)
November 200825/11/2008Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney DiseaseRandomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic KidneyDrug: tripterygium wilfordii;Drug: EmodinZhi-Hong Liu, M.D.NULLTerminated15 Years70 YearsBoth300N/AChina
178NCT00784030
(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
179NCT00759369
(ClinicalTrials.gov)
September 200824/9/2008Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)Water as Therapy in Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseOther: Water prescriptionUniversity of KansasNULLCompleted18 Years50 YearsBoth11N/AUnited States
180NCT01009957
(ClinicalTrials.gov)
June 20086/11/2009Everolimus on CKD Progression in ADPKD PatientsEverolimus on CKD (Chronic Kidney Disease) Progression in ADPKD PatientsPolycystic Kidney DiseasesDrug: EverolimusA. Manzoni HospitalNULLTerminated18 YearsN/ABoth71Phase 2/Phase 3Italy
181NCT00771888
(ClinicalTrials.gov)
April 200813/10/2008Open-Label Extension of LOCKCYST TrialOpen-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic LiversPolycystic Liver Disease;Hepatomegaly;Liver Diseases;Polycystic Kidney;Autosomal DominantDrug: lanreotideRadboud UniversityIpsenActive, not recruiting18 Years88 YearsBoth54Phase 2/Phase 3Belgium;Netherlands
182EUCTR2007-005047-21-IT
(EUCTR)
24/12/200702/07/2008Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA IIEffects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA II Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 9.1;Level: LLT;Classification code 10010428;Term: Congenital cystic kidney disease
Trade Name: RAPAMUNE*100CPR RIV 1MG
INN or Proposed INN: Sirolimus
Trade Name: RAPAMUNE*30CPR RIV 2MG
INN or Proposed INN: Sirolimus
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly
183EUCTR2007-006557-25-IT
(EUCTR)
20/12/200718/12/2007RAPAMYCIN FOR TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE - RAPYD-STUDYRAPAMYCIN FOR TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE - RAPYD-STUDY ADPKD type I
MedDRA version: 9.1;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders
Trade Name: RAPAMUNE*100CPR RIV 1MG
INN or Proposed INN: Sirolimus
Product Name: Ramipril
INN or Proposed INN: Ramipril
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALENULLNot RecruitingFemale: yes
Male: yes
Italy
184NCT00541853
(ClinicalTrials.gov)
December 20079/10/2007CCB Safety Study in Treatment of Hypertension of ADPKDComparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD PatientsKidney, Polycystic, Autosomal DominantDrug: Candesartan;Drug: Candesartan and Cilnidipine;Drug: Candesartan plus non-CCB agentsKyorin UniversityMinistry of Health, Labour and Welfare, JapanNot yet recruiting20 Years60 YearsBoth150Phase 4Japan
185NCT00565097
(ClinicalTrials.gov)
October 200728/11/2007Lanreotide as Treatment of Polycystic LiversLong-Acting Lanreotide as a Volume Reducing Treatment of Polycystic LiversPolycystic Liver Disease;Hepatomegaly;Liver Diseases;Polycystic Kidney, Autosomal DominantDrug: Placebo;Drug: LanreotideRadboud UniversityIpsenCompleted18 Years88 YearsBoth38Phase 2/Phase 3Belgium;Netherlands
186EUCTR2006-001485-16-FR
(EUCTR)
20/08/200723/07/2007A 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) - ADPKDA multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD polycystic kidney disease
MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease
Product Name: Certican
Product Code: RAD001
INN or Proposed INN: Everolimus
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
300France;Austria;Germany
187EUCTR2006-002768-24-DE
(EUCTR)
03/05/200715/12/2006A 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 DiseaseA Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;Denmark;Germany;Italy;United Kingdom
188EUCTR2006-002768-24-GB
(EUCTR)
23/04/200707/12/2006A 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 DiseaseA Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot Recruiting Female: yes
Male: yes
1500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Denmark;Germany;Italy;United Kingdom
189EUCTR2006-002768-24-FR
(EUCTR)
18/04/200729/12/2006A 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 DiseaseA Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Otsuka Maryland Research Institute, Inc.NULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;Belgium;Denmark;Germany;Italy;United Kingdom
190EUCTR2006-002768-24-IT
(EUCTR)
16/04/200723/07/2007Phase III multicenter, double blind,placebo controlled, parallel arm trial to determine long-term safety and efficacy of oral tolvaptan tablet regimen in adult subjects with autosomal dominant polycystic kidney diseasePhase III multicenter, double blind,placebo controlled, parallel arm trial to determine long-term safety and efficacy of oral tolvaptan tablet regimen in adult subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 14.1;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: tolvaptan
Product Code: NA
INN or Proposed INN: tolvaptan
Product Name: tolvaptan
Product Code: NA
INN or Proposed INN: tolvaptan
Product Name: tolvaptan
Product Code: NA
INN or Proposed INN: tolvaptan
OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INCNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;Denmark;Germany;United Kingdom;Italy
191EUCTR2006-002768-24-BE
(EUCTR)
26/03/200705/12/2006A 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 DiseaseA Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization. Inc.NULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;Belgium;Denmark;Germany;Italy;United Kingdom
192NCT00491517
(ClinicalTrials.gov)
March 200725/6/2007Sirolimus Treatment in Patients With Autosomal Dominant Polycystic Kidney Disease: Renal Efficacy and SafetySirolimus Treatment in Patients With ADPKDPolycystic KidneyDrug: Sirolimus;Drug: conventional therapyMario Negri Institute for Pharmacological ResearchNULLCompleted18 Years80 YearsBoth22Phase 2Italy
193EUCTR2006-003427-37-IT
(EUCTR)
05/02/200727/12/2006Sirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - NDSirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - ND Autosomal-Dominant Polycystic Kidney Disease ADPKD
MedDRA version: 9.1;Level: LLT;Classification code 10010428;Term: Congenital cystic kidney disease
Trade Name: RAPAMUNE*30CPR RIV 1MG
INN or Proposed INN: Sirolimus
Trade Name: RAPAMUNE*30CPR RIV 2MG
INN or Proposed INN: Sirolimus
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
16 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly
194EUCTR2006-002768-24-DK
(EUCTR)
26/01/200729/11/2006A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease - -A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease - - Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan (OPC-41061)
Product Code: Tolvaptan (OPC-41061)
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;Denmark;Germany;Italy;United Kingdom
195JPRN-JapicCTI-070402
25/1/200721/05/2007Tolvaptan efficacy and safety in management of polycystic kidney desease and its outcomes (TEMPO3/4)A phase 3, multi-center, double-blind, placebo-controlled, parallel-arm trial to determine long-term safety and efficacy of oral tolvaptan regimens in adult subjects with autosomal dominant polycystic kidney disease (ADPKD) Autosomal dominant polycystic kidney disease (ADPKD)Intervention name : OPC-41061 (tolvaptan)
INN of the intervention : Tolvaptan
Dosage And administration of the intervention : Oral, 45/15 mg
Intervention name : OPC-41061 (tolvaptan)
INN of the intervention : Tolvaptan
Dosage And administration of the intervention : Oral, 60/30 mg
Intervention name : OPC-41061 (tolvaptan)
INN of the intervention : Tolvaptan
Dosage And administration of the intervention : Oral, 90/30 mg
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Oral
Otsuka Pharmaceutical Co., Ltd.NULLcomplete2050BOTH1500Phase 3Japan, North America, South America, Europe, Oceania
196NCT00428948
(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
197NCT00426153
(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
198EUCTR2006-001485-16-AT
(EUCTR)
15/12/200616/11/2006A 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) - ADPKDA multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD polycystic kidney disease
MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease
Product Name: Certican Tabletten
Product Code: RAD001
INN or Proposed INN: Everolimus
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
300France;Austria;Germany
199NCT00414440
(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
200NCT00456365
(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
201EUCTR2006-001485-16-DE
(EUCTR)
25/10/200619/01/2007A 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) - ADPKDA multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD polycystic kidney disease
MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease
Product Name: Certican Tabletten
Product Code: RAD001
INN or Proposed INN: Everolimus
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
300France;Austria;Germany
202NCT00286156
(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
203NCT00598377
(ClinicalTrials.gov)
September 200631/12/2007Adrenal Functions in Autosomal Dominant Polycystic Kidney DiseaseAssessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: TetracosactinIstanbul UniversityNULLCompleted20 Years56 YearsBoth49N/ATurkey
204NCT00346918
(ClinicalTrials.gov)
June 200622/6/2006Sirolimus (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: StandardUniversity of ZurichNULLCompleted18 Years40 YearsBoth100Phase 3Switzerland
205NCT00345137
(ClinicalTrials.gov)
May 200624/6/2006Effects of Systemic NO-Inhibition on Renal Hemodynamics in Patiens With Polycystic Kidney Disease and Chronic GlomerulonephritisPhase 1 Study of Systemic Effects of Ng-Monomethyl-L-Arginine on Renal Hemodynamics in Patients With Polycystic Kidney Disease and Chronic GlomerulonephritisADPKD;GlomerulonephritisDrug: Ng-monomethyl-L-arginine (drug)Regional Hospital HolstebroNULLCompleted20 Years60 YearsBoth75Phase 1NULL
206NCT00841568
(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
207NCT00309283
(ClinicalTrials.gov)
April 200630/3/2006Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up StudyEffect of a Long-acting Somatostatin on Disease Progression in Nephropathy Due to Autosomal Dominant Polycystic Kidney Disease: a Long-term Three Year Follow up StudyAutosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: Long-acting somatostatin;Other: Saline solutionMario Negri Institute for Pharmacological ResearchNULLCompleted18 Years75 YearsBoth78Phase 3Italy
208EUCTR2005-005552-41-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
Trade Name: Sandostatina Lar IM Fl 20mg +2F
Product Name: octreotide
INN or Proposed INN: Octreotide
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noItaly
209NCT01885559
(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
210NCT00283686
(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
211NCT00413777
(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
212EUCTR2005-003182-16-GB
(EUCTR)
26/08/200529/07/2005Blood 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 diseaseTrade Name: CARDURA
Product Name: DOXAZOSIN
Trade Name: MONOCOR
Product Name: BISOPROLOL
Trade Name: ZESTRIL
Product Name: LISINOPRIL
Trade Name: ISTIN
Product Name: AMLODIPINE
Trade Name: AMIAS
Product Name: CANDESARTAN
Trade Name: APRINOX
Product Name: BENDROFLUMETHIAZIDE
Addenbrooke's Hospital TrustNULLNot Recruiting Female: yes
Male: yes
42 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
213NCT00067977
(ClinicalTrials.gov)
October 20033/9/2003Clinical Trial to Slow the Progression of ADPKDKidney, Polycystic;Kidney, Polycystic, Autosomal DominantDrug: anti-hypertensive medicationsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLNot yet recruiting15 Years65 YearsBothN/AUnited States
214EUCTR2020-005992-10-DE
(EUCTR)
26/05/2021A trial to see if tolvaptan is safe in infants and children who at enrollment are 28 days to less than 18 years old with Autosomal Recessive Polycystic Kidney Disease (ARPKD)A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 18 years of Age with Autosomal Recessive Polycystic Kidney Disease (ARPKD) Autosomal Recessive Polycystic Kidney Disease (ARPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036047;Term: Polycystic kidney, autosomal recessive;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: SAMSCA 7.5 mg oral tablet
Product Name: Tolvaptan 7.5 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc 30 mg Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 50mg Granules
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNAFemale: yes
Male: yes
10Phase 3United States;Belgium;Germany;United Kingdom;Italy
215EUCTR2020-005991-36-DE
(EUCTR)
26/05/2021A trial to see if tolvaptan can delay dialysis in infants and children who at enrollment are 28 days to less than 12 weeks old with Autosomal Recessive Polycystic Kidney Disease (ARPKD)A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 12 weeks of Age with Autosomal Recessive Polycystic Kidney Disease (ARPKD) Autosomal Recessive Polycystic Kidney Disease (ARPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036047;Term: Polycystic kidney, autosomal recessive;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tolvaptan 50mg Granules
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNAFemale: yes
Male: yes
20Phase 3United States;Belgium;Germany;United Kingdom;Italy
216EUCTR2019-003521-21-ES
(EUCTR)
28/05/2020A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Belgium;Spain;Germany;Netherlands;Italy