Clinical trials: Polycystic Kidney
Chronic Kidney Diseases, Alport Syndrome
An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with…
- Conditions
- Chronic Kidney Diseases, Alport Syndrome, Autosomal Dominant Polycystic Kidney
- Trial name
- EAGLE (NCT03749447)
- Testing
- Bardoxolone methyl
- Where
- 87 sites in United States, Australia and 4 more
- Volunteers
- 270 people
- Sponsor
- Biogen
Autosomal Dominant Polycystic Kidney, ADPKD
A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD.
- Trial name
- FALCON (NCT03918447)
- Testing
- Bardoxolone methyl oral capsule
- Where
- 137 sites in United States, Australia and 8 more
- Volunteers
- 667 people
- Sponsor
- Biogen
Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)
- Trial name
- NCT02160145
- Testing
- Tolvaptan (OPC-41061)
- Where
- 230 sites in United States, Argentina and 20 more
- Volunteers
- 1,370 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
IgA Nephropathy, CKD Associated With Type 1 Diabetes
A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes…
- Conditions
- IgA Nephropathy, CKD Associated With Type 1 Diabetes, Focal Segmental Glomerulosclerosis, Autosomal Dominant Polycystic Kidney
- Trial name
- PHOENIX (NCT03366337)
- Testing
- Bardoxolone methyl capsules
- Where
- 30 sites in United States
- Volunteers
- 103 people
- Sponsor
- Biogen
Autosomal Dominant Polycystic Kidney Disease （ADPKD)
A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).
- Trial name
- NCT01280721
- Testing
- tolvaptan
- Where
- 7 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Tolvaptan Extension Study in Participants With ADPKD
To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.
- Trial name
- TEMPO 4/4 (NCT01214421)
- Testing
- Tolvaptan
- Where
- 97 sites in United States, Argentina and 11 more
- Volunteers
- 1,083 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autosomal Dominant Polycystic Kidney, ADPKD
Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
The goal of the study was to compare and evaluate safety and efficacy of tesevatinib 50 milligrams (mg) versus placebo in participants with autosomal dominant polycystic kidney disease (ADPKD).
- Trial name
- NCT03203642
- Testing
- Tesevatinib
- Where
- 19 sites in United States
- Volunteers
- 80 people
- Sponsor
- Kadmon, a Sanofi Company
Polycystic Kidney Disease, Adult
Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303
This is a Phase 3, open-label, roll-over study to demonstrate the continued hepatic and non-hepatic safety and renal efficacy of lixivaptan in participants with ADPKD who previously experienced abnormal liver chemistry test…
- Trial name
- NCT05208866
- Testing
- Lixivaptan
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Palladio Biosciences
Autosomal Dominant Polycystic Kidney Disease
Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
The purpose of the trial was to determine the short-term effects of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) at various levels of renal function.
- Trial name
- NCT01336972
- Testing
- Tolvaptan
- Where
- Netherlands
- Volunteers
- 29 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autosomal Dominant Polycystic Kidney Disease
8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.
- Trial name
- NOCTURNE (NCT01451827)
- Testing
- Tolvaptan MR, Tolvaptan IR
- Where
- 35 sites in United States
- Volunteers
- 178 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Polycystic Kidney, Autosomal Dominant
Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD).
- Trial name
- NCT02251275
- Testing
- Tolvaptan
- Where
- 210 sites in United States, Argentina and 18 more
- Volunteers
- 1,803 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Polycystic Kidney Disease, Autosomal Dominant
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
- Trial name
- TEMPO3:4 (NCT00428948)
- Testing
- Tolvaptan
- Where
- 133 sites in United States, Argentina and 13 more
- Volunteers
- 1,445 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autosomal Dominant Polycystic Kidney Disease
Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals of this trial are two-fold: 1.
- Trial name
- NCT01210560
- Testing
- Tolvaptan MR, Tolvaptan IR
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autosomal Dominant Polycystic Kidney Disease
A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
This is an exploratory, randomized, double-blind, placebo-controlled, parallel group, multicenter, proof of concept study (Phase 2a), evaluating orally administered GLPG2737 for a double-blind (DB) treatment period of 52 weeks…
- Trial name
- NCT04578548
- Testing
- GLPG2737
- Where
- 20 sites in Belgium, Czechia and 5 more
- Volunteers
- 66 people
- Sponsor
- Lakefront Biotherapeutics NV
Polycystic Liver Disease
A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD
The purpose of the trial is to compare the effectiveness and safety of 2 treatment regimens of CAM2029 (given weekly or every 2 weeks) to placebo in participants with symptomatic PLD, either isolated as in autosomal dominant PLD…
- Trial name
- POSITANO (NCT05281328)
- Testing
- CAM2029
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 71 people
- Sponsor
- Camurus AB
Polycystic Kidney, Autosomal Dominant
A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients
Primary Objective: To determine the effect of venglustat on the rate of total kidney volume (TKV) growth (Stage 1) and estimated glomerular filtration rate (eGFR) decline in participants at risk of rapidly progressive Autosomal…
- Trial name
- STAGED-PKD (NCT03523728)
- Testing
- Venglustat
- Where
- 95 sites in United States, Argentina and 21 more
- Volunteers
- 478 people
- Sponsor
- Genzyme, a Sanofi Company
Autosomal Dominant Polycystic Kidney Disease
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
This is a Phase 2, open-label, parallel-group, multiple dose study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of lixivaptan in Autosomal Dominant Polycystic Kidney…
- Trial name
- NCT03487913
- Testing
- Lixivaptan
- Where
- 13 sites in United States
- Volunteers
- 31 people
- Sponsor
- Palladio Biosciences
Polycystic Kidney, Autosomal Dominant
Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD
The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical setting in Japan.
- Trial name
- NCT02847624
- Testing
- tolvaptan
- Where
- Japan
- Volunteers
- 1,802 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Congenital Cystic Kidney Disease
Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat
Primary Objective: -To determine the effect of early versus delayed treatment with venglustat on the total kidney volume (TKV) in participants at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD).
- Trial name
- STAGED-PKD-EXT (NCT04705051)
- Testing
- Venglustat GZ402671
- Where
- 11 sites in United States, Australia and 6 more
- Volunteers
- 24 people
- Sponsor
- Sanofi
Autosomal Dominant Polycystic Kidney Disease
Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease
This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney expansion as well as worsening of renal function in patients with ADPKD and whether the application of 5 mg/day everolimus as…
- Trial name
- NCT00414440
- Testing
- Everolimus
- Where
- 24 sites in Austria, France and 1 more
- Volunteers
- 431 people
- Sponsor
- Novartis Pharmaceuticals