Clinical trials: Cystic Kidney Diseases
Polycystic Kidney, Autosomal Recessive
A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
This study evaluates safety and tolerability of a single ascending dose of a tesevatinib liquid formulation administered to pediatric subjects with ARPKD.
- Trial name
- NCT03096080
- Testing
- Tesevatinib
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Kadmon Corporation, LLC
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.
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
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
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.
Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax
Special Drug Use Investigation of Ciproxan Injection in Pediatrics
The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.
- Trial name
- NCT02555059
- Testing
- Cipro (Ciprofloxacin, BAYQ3939)
- Where
- Japan
- Volunteers
- 48 people
- Sponsor
- Bayer
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
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, 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.
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, 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)
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)
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 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 (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.
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
Advanced Solid Tumor
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also…
- Trial name
- TITER (NCT07166601)
- Testing
- M0324, Pembrolizumab, mFOLFIRINOX
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 77 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Solid Tumor, Lymphoma
Study of Oral PXD101 in Patients With Advanced Solid Tumors or Lymphoma
This is a Phase I dose escalation study of PXD101 administered orally. Oral belinostat will be given once or twice daily at various dosing schedules to patients with solid tumors.
- Trial name
- NCT00413075
- Testing
- oral belinostat
- Where
- 6 sites in United States, Denmark and 1 more
- Volunteers
- 121 people
- Sponsor
- Valerio Therapeutics
ADPKD (autosomal Dominant Polycystic Kidney Disease)
Study to Evaluate the Drug-drug Interaction of JMKX003142 in Healthy Subjects
To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of JMKX003142 in healthy subjects.
- Trial name
- NCT06658964
- Testing
- Cohort 1: JMKX003142 and itraconazole, Cohort 2: JMKX003142 and rifampicin
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jemincare