Clinical trials: Autosomal Dominant Polycystic Kidney Disease
- Condition Autosomal Dominant Polycystic Kidney Disease
- Funder type Industry (pharma, biotech, devices)
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)
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
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
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.
Polycystic Kidney, Autosomal Dominant
A Safety, Pharmacokinetic & Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease
The primary objective of this study Phase 1b was to determine the safety, plasma pharmacokinetics, and maximum tolerated dose (MTD) of tesevatinib when administered to participants with autosomal dominant polycystic kidney…
- Trial name
- NCT01559363
- Testing
- Tesevatinib
- Where
- 11 sites in United States
- Volunteers
- 69 people
- Sponsor
- Kadmon, a Sanofi Company
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease
To evaluate the safety and therapeutic effectiveness of tolvaptan when administered to slow the progression of cyst development and renal function insufficiency in adult Korean patients diagnosed with rapidly progressive ADPKD…
- Trial name
- ESSENTIAL (NCT03949894)
- Testing
- Tolvaptan
- Where
- 18 sites in South Korea
- Volunteers
- 118 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
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
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, 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
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 (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
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.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)
The primary objective of the study is to assess the long term safety of treatment with tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD).
- Trial name
- NCT02964273
- Testing
- Tolvaptan
- Where
- 20 sites in Belgium, Germany and 2 more
- Volunteers
- 91 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).
- Trial name
- PIONEER-PKD (NCT07228364)
- Testing
- AZD1613 - Part A, AZD1613 - Part B
- Where
- 15 sites in United States, China and 1 more
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Healthy Volunteers, Polycystic Kidney, Autosomal Dominant
Effect of Venglustat in Patients With Renal Impairment
Primary Objective: To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics (PK) of Venglustat following a single dose.
- Trial name
- NCT03687554
- Testing
- Venglustat GZ/SAR402671
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
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.
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
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
The primary purpose of this study is to evaluate the plasma PK of JMKX003142 following a single dose in participants with mild and moderate hepatic impairment compared to matched healthy participants with normal hepatic function.
- Trial name
- NCT07909070
- Testing
- JMKX003142
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jemincare
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