Clinical trials: Autosomal Dominant Polycystic Kidney
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
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)
Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives
The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.
- Trial name
- NCT07792408
- Testing
- VX-407, LNG/EE, NGM/EE
- Where
- Canada
- Volunteers
- 148 people, healthy volunteers welcome
- 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 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.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101
Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101 study.
- Trial name
- NCT02616055
- Testing
- tesevatinib
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Kadmon Corporation, LLC
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study of Tamibarotene in Patients With ADPKD
Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
- Trial name
- NCT06289998
- Testing
- Tamibarotene
- Where
- 8 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Rege Nephro Co., Ltd.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of VX-407 in healthy participants.
- Trial name
- NCT07022119
- Testing
- VX-407
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
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.
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
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.
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
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
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 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
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.
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 (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
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
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of VX-407 following a single oral dose.
- Trial name
- NCT07868926
- Testing
- 14C-VX-407
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated