Clinical trials: ADPKD
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)
The purpose of the study is to evaluate the effect of VX-407 on height-adjusted total kidney volume (htTKV), safety, tolerability, and pharmacokinetics (PK) of VX-407.
- Trial name
- AGLOW (NCT07161037)
- Testing
- VX-407
- Where
- 43 sites in United States, Belgium and 6 more
- Volunteers
- 26 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Polycystic Kidney Disease, Autosomal Dominant
A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney Disease
Primary Objective To assess the dose response relationship between RGLS4326 and ADPKD biomarkers Secondary Objectives To characterize the pharmacokinetic (PK) properties of RGLS4326 in plasma and urine To assess the safety and…
- Trial name
- NCT04536688
- Testing
- RGLS4326
- Where
- 12 sites in United States
- Volunteers
- 19 people
- Sponsor
- Regulus Therapeutics 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.
Autosomal Dominant Polycystic Kidney Disease, ADPKD
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
Primary Objectives To assess the safety and tolerability of RGLS8429 To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) To…
- Conditions
- Autosomal Dominant Polycystic Kidney Disease, ADPKD, Polycystic Kidney, Autosomal Dominant
- Trial name
- NCT05521191
- Testing
- RGLS8429
- Where
- 21 sites in United States
- Volunteers
- 68 people
- Sponsor
- Regulus Therapeutics Inc.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease
The purpose of this study is to estimate the prevalence, demographic, and clinical characteristics of PKD1/2 gene variant groups in the ADPKD population.
- Trial name
- NCT06747572
- Where
- 45 sites in United States, Belgium and 7 more
- Volunteers
- 401 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Kidney Disease
A Study to Evaluate the Safety, Tolerability, and Effects on Blood and Urine Markers of Single Ascending Dose of GSK4771261 in Healthy Participants and Participants With Autosomal Dominant Polycystic Kidney Disease
This is a study where a new drug, called GSK4771261 is being tested. Neither the study doctors, study staff or participants will be aware of what treatment is being given.
- Trial name
- NCT06734234
- Testing
- GSK4771261
- Where
- 23 sites in United States, Belgium and 6 more
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Study of RGLS8429 in Healthy Volunteers
Primary Objective To assess the safety and tolerability of single ascending doses of RGLS8429 Secondary Objectives To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of a single SC dose of…
- Trial name
- NCT05429073
- Testing
- RGLS8429
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Regulus Therapeutics Inc.
Polycystic Kidney Disease, Adult, ADPKD
Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
This is a Phase 3, open-label, repeat-dose study designed to assess liver safety, non-liver safety, and efficacy of lixivaptan in participants who previously experienced liver chemistry test abnormalities while treated with…
- Trial name
- ALERT (NCT04152837)
- Testing
- Lixivaptan
- Where
- 6 sites in United States
- Volunteers
- 7 people
- Sponsor
- Palladio Biosciences
Autosomal Dominant Polycystic Kidney, ADPKD
Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease
This is a Phase 3 trial consisting of a 2-arm, double-blind, placebo-controlled, randomized phase (Part 1) followed by a single-arm open-label phase (Part 2) to demonstrate the efficacy and safety of lixivaptan in participants…
- Trial name
- ACTION (NCT04064346)
- Testing
- Lixivaptan
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 12 people
- Sponsor
- Palladio Biosciences
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.
Polycystic Kidney, Autosomal Dominant
Bosutinib For Autosomal Dominant Polycystic Kidney Disease
This purpose of this study is to determine if bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with a total kidney volume greater than or…
- Trial name
- NCT01233869
- Testing
- Bosutinib
- Where
- 67 sites in United States, Australia and 15 more
- Volunteers
- 172 people
- Sponsor
- Pfizer
ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Trial of JMKX003142 in Participants With Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive…
- Trial name
- NCT06800651
- Testing
- JMKX003142 will be administered orally, Plcacebo
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Jemincare
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.
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
ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Mass Balance and Absolute Bioavailability Study of JMKX003142 In Healthy Volunteers
A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral JMKX003142.
- Trial name
- NCT07463053
- Testing
- [14C]JMKX003142, JMKX003142 tablets, [14C]JMKX003142 solution for infusion
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Jemincare
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants.
- Trial name
- NCT06345755
- Testing
- VX-407, Midazolam
- Where
- 2 sites in United States, Canada
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
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
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Canadian Medical Assessment of JINARC™ Outcomes Registry
This study is part of the Health Canada approval requirement for JINARC™ (tolvaptan) and is an observational, non-interventional study (NIS) describing the impact of tolvaptan on ADPKD-related burden of illness as measured with a…
- Trial name
- C-MAJOR (NCT02925221)
- Where
- 6 sites in Canada
- Volunteers
- 530 people
- Sponsor
- Otsuka Canada Pharmaceutical Inc.
Safety
Samsca PMS in ADPKD Patients
This is a Post-Marketing Surveillance study(PMS) of Samsca® tablets in actual use in cases to slow the progression of cyst development and renal insufficiency in accordance with Korean regulations on Risk Management Plan(RMP) and…
- Trial name
- NCT03406286
- Testing
- Tolvaptan
- Where
- South Korea
- Volunteers
- 2,067 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Phase 1 Study to Evaluate the Safety and Tolerability of Intravenously Administered PYC-003
This is a Phase 1, First-in-Human study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of PYC-003 in healthy adult participants and adult participants with confirmed PKD1…
- Trial name
- NCT06714006
- Testing
- PYC-003
- Where
- 12 sites in Australia, Hong Kong and 1 more
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- PYC Therapeutics