Clinical trials: ADPKD
ADPKD (Autosomal Dominant Polycystic Kidney Disease)
A Phase 1 Study of Single and Multiple Ascending Doses of GV-100
This is a first-in-human, multi-part clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), food effect, and drug-drug interaction (DDI) potential of GV-100 following oral administration in healthy…
- Trial name
- NCT07788014
- Testing
- GV-100
- Where
- Australia
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Gilva Therapeutics Inc.
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.
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
Polycystic Kidney, Autosomal Dominant
Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease…
- Trial name
- TEMPO 2:4 (NCT00413777)
- Testing
- Tolvaptan
- Where
- 11 sites in United States
- Volunteers
- 46 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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 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
ADPKD (Autosomal Dominant Polycystic Kidney Disease)
A Study to Investigate the Effects of JMKX003142 on QTc Interval in Healthy Adults
The primary objective of this study is to assess the effect of a therapeutic and supratherapeutic oral dose of JMKX003142 on the corrected cardiac QT interval relative to a placebo in healthy participants
- Trial name
- NCT07470177
- Testing
- JMKX003142 tablets
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jemincare
Autosomal Dominant Polycystic Kidney Disease
ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys.
- Trial name
- ANCHOR (NCT06902558)
- Testing
- ABBV-CLS-628
- Where
- 91 sites in United States, Australia and 10 more
- Volunteers
- 240 people
- Sponsor
- Calico Life Sciences LLC
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
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants
The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE, norethindrone (NET) and EE and drospirenone (DRSP) and EE.
- Trial name
- NCT07074327
- Testing
- VX-407, LNG/EE, NGM/EE
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Autosomal Dominant Polycystic Kidney Disease
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening).
- Trial name
- NCT01022424
- Testing
- OPC-41061
- Where
- Japan
- Volunteers
- 13 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Autosomal Dominant Polycystic Kidney
To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers
The study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Oral AL01211 in healthy volunteers
- Trial name
- NCT04908462
- Where
- Australia
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- AceLink Therapeutics, Inc.
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
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.
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
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
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
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
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 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.