Clinical trials: Renal Hypoxia
Anemia, Chronic Kidney Disease
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.
- Trial name
- NCT01906489
- Testing
- AKB-6548
- Where
- 47 sites in United States
- Volunteers
- 210 people
- Sponsor
- Akebia Therapeutics
Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
- Trial name
- NCT02648347
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 439 sites in United States, Argentina and 18 more
- Volunteers
- 1,751 people
- Sponsor
- Akebia Therapeutics
Anemia, Non-dialysis Dependent Chronic Kidney Disease
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese…
- Trial name
- NCT03054337
- Testing
- Vadadustat
- Where
- 18 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Akebia Therapeutics
Renal Cell Carcinoma
Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
Substudy 03C is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).
- Trial name
- NCT07049926
- Testing
- Belzutifan, Zanzalintinib
- Where
- 33 sites in United States, Chile and 6 more
- Volunteers
- 140 people
- Sponsor
- Merck Sharp & Dohme LLC
Anemia, Dialysis-Dependent Chronic Kidney Disease
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)
- Trial name
- NCT02892149
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 278 sites in United States, Argentina and 16 more
- Volunteers
- 3,554 people
- Sponsor
- Akebia Therapeutics
Renal Cell Carcinoma
A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)
The purpose of this study is to evaluate the efficacy and safety of belzutifan monotherapy and belzutifan plus palbociclib combination therapy in participants with advanced clear-cell renal cell carcinoma (ccRCC) who experienced…
- Trial name
- NCT05468697
- Testing
- Belzutifan, Palbociclib
- Where
- 13 sites in United States, Australia and 1 more
- Volunteers
- 60 people
- Sponsor
- Merck Sharp & Dohme LLC
Carcinoma, Renal Cell
A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)
The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell…
- Trial name
- NCT05239728
- Testing
- Belzutifan, Pembrolizumab
- Where
- 285 sites in United States, Australia and 30 more
- Volunteers
- 1,800 people
- Sponsor
- Merck Sharp & Dohme LLC
ccRCC, Clear Cell Renal Cell Carcinoma
A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma
The goal of the Phase 1 portion is to identify the maximum tolerated dose (MTD) and/or the recommended doses for expansion (RDEs) of NKT2152. The Phase 2 portion will evaluate the efficacy of NKT2152 in ccRCC.
- Conditions
- ccRCC, Clear Cell Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasms
- Trial name
- NCT05119335
- Testing
- Oral NKT2152
- Where
- 13 sites in United States
- Volunteers
- 120 people
- Sponsor
- NiKang Therapeutics, Inc.
Anemia, Dialysis-Dependent Chronic Kidney Disease
Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).
- Trial name
- NCT02865850
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 118 sites in United States, Argentina and 9 more
- Volunteers
- 369 people
- Sponsor
- Akebia Therapeutics
ccRCC, Clear Cell Renal Cell Carcinoma
Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc)
The goal of the Lead-in phase of the study is to evaluate the safety, efficacy, pharmacokinetics (PK) and determine recommended dose for expansion (RDE) of NKT2152 in combination with palbociclib (Doublet) and with palbociclib…
- Conditions
- ccRCC, Clear Cell Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasms
- Trial name
- NCT05935748
- Testing
- NKT2152, palbociclib, sasanlimab
- Where
- 8 sites in United States
- Volunteers
- 18 people
- Sponsor
- NiKang Therapeutics, Inc.
Overweight, Obesity
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D). The study will last about 56 weeks and include up to 12 visits.
- Conditions
- Overweight, Obesity, Chronic Kidney Disease, Type 2 Diabetes
- Trial name
- TREASURE-CKD (NCT05536804)
- Testing
- Tirzepatide
- Where
- 27 sites in United States, Austria and 4 more
- Volunteers
- 134 people
- Sponsor
- Eli Lilly and Company
Carcinoma, Renal Cell
A Study of Belzutifan (MK-6482) in Participants With Advanced Clear Cell Renal Cell Carcinoma (MK-6482-018)
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of escalating doses of belzutifan as second line positive (2L+) treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).
- Trial name
- NCT04846920
- Testing
- Belzutifan
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- Merck Sharp & Dohme LLC
Carcinoma, Renal Cell
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study
The goal of this China extension study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line…
- Trial name
- NCT05899049
- Testing
- Pembrolizumab, Belzutifan, Pembrolizumab/Quavonlimab
- Where
- 17 sites in China
- Volunteers
- 251 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Clear Cell Renal Cell Carcinoma
A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC
This is a Phase Ib/III, randomized, multicenter, global study evaluating the efficacy and safety of volrustomig in combination with casdatifan for the first-line (1L) treatment of participants with advanced clear cell renal cell…
- Trial name
- eVOLVE-RCC02 (NCT07000149)
- Testing
- Volrustomig, Casdatifan
- Where
- 3 sites in Australia, South Korea
- Volunteers
- 9 people
- Sponsor
- AstraZeneca
Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
- Trial name
- NCT02680574
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 503 sites in United States, Argentina and 28 more
- Volunteers
- 1,725 people
- Sponsor
- Akebia Therapeutics
Anemia of Chronic Kidney Disease
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease
This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of Chronic Kidney Disease (CKD) after conversion from an Erythropoiesis Stimulating Agent…
- Trial name
- CONVERSION (NCT05082571)
- Testing
- vadadustat
- Where
- United States
- Sponsor
- Akebia Therapeutics
Anemia, Dialysis-Dependent Chronic Kidney Disease
Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease (DD-CKD) who are hyporesponsive to erythropoiesis…
- Trial name
- NCT03140722
- Testing
- vadadustat, epoetin alfa
- Where
- 18 sites in United States
- Volunteers
- 2 people
- Sponsor
- Akebia Therapeutics
Anemia, End Stage Renal Disease
16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with end stage renal disease undergoing chronic hemodialysis.
- Trial name
- NCT02260193
- Testing
- AKB-6548
- Where
- 16 sites in United States
- Volunteers
- 94 people
- Sponsor
- Akebia Therapeutics
Carcinoma, Renal Cell
A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)
This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy.
- Trial name
- NCT04489771
- Testing
- Belzutifan
- Where
- 48 sites in United States, Australia and 7 more
- Volunteers
- 154 people
- Sponsor
- Merck Sharp & Dohme LLC
Anemia, Dialysis Dependent Chronic Kidney Disease
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese…
- Trial name
- NCT03054350
- Testing
- Vadadustat
- Where
- 18 sites in Japan
- Volunteers
- 60 people
- Sponsor
- Akebia Therapeutics