Clinical trials: Kidney Diseases
Chronic Kidney Diseases
Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease
A Single arm, Open-labelled, Dose-escalation, Single-center, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Autologous Urine-derived Stem Cells, 『KDSTEM Inj.』, in Patients with Chronic Kidney…
- Trial name
- NCT06071143
- Testing
- KDSTEM Inj.
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- EHL Bio Co., Ltd.
Heart Failure, Hyperkalemia
Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia
The CARE-HK in HF is a registry study based on the hypothesis that adherence to guidelines is associated with improved real-world outcomes for heart failure (HF) patients.
- Trial name
- CARE-HK (NCT04864795)
- Where
- 116 sites in United States, Austria and 5 more
- Volunteers
- 2,636 people
- Sponsor
- Vifor (International) Inc.
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.
Pure Red-Cell Aplasia, Chronic Kidney Failure
Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia Among Patients With Chronic Kidney Failure
The purpose of this study is to estimate the incidence rate of pure red cell aplasia (PRCA; aplastic anemia) mediated by erythropoietin (EPO) antibodies in patients who are receiving subcutaneous (s.c.) epoetin alfa (polysorbate…
- Trial name
- PRIMS (NCT00391287)
- Where
- 387 sites in Australia, Belgium and 13 more
- Volunteers
- 15,334 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
X-linked Hypophosphatemia, Tumor-Induced Osteomalacia
Expanded Access to Burosumab
Individual patient expanded access requests may be considered for patients who have no other treatment options
- Trial name
- NCT03775187
- Testing
- Burosumab
- Sponsor
- Kyowa Kirin Co., Ltd.
Gout
Mild, Moderate and Severe Renal Impairment Study
This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
- Trial name
- NCT02219516
- Testing
- RDEA3170
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- Ardea Biosciences, Inc.
Carcinoma, Renal Cell
Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination.
- Trial name
- NCT00267748
- Testing
- Sunitinib Malate Continuous Daily Dosing, Sunitinib Malate Schedule 4/2
- Where
- 156 sites in United States
- Volunteers
- 317 people
- Sponsor
- Pfizer
Renal Impairment, Healthy Volunteers
A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954
The purpose of this study is to evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of…
- Trial name
- NCT03296787
- Testing
- TAK-954
- Where
- 4 sites in Czechia, Hungary
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Takeda
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.
End Stage Renal Disease, Continuous Ambulatory Peritoneal Dialysis
Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR
Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange.
- Trial name
- ECOS (NCT01093547)
- Testing
- Blood samples, Measure of peritoneal ultrafiltrates
- Where
- Colombia
- Sponsor
- Vantive Health LLC
Diabetes Mellitus, Type 2
Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment
- Trial name
- NCT00663260
- Testing
- Dapagliflozin
- Where
- 96 sites in United States, Argentina and 11 more
- Volunteers
- 631 people
- Sponsor
- AstraZeneca
Metastatic Renal Cell Carcinoma
A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
The purpose of this study was to evaluate the progression free survival (PFS), based on investigator radiologic review, of AGS-16C3F compared to axitinib in subjects with metastatic renal cell carcinoma.
- Trial name
- NCT02639182
- Testing
- AGS-16C3F, Axitinib
- Where
- 26 sites in United States, Canada
- Volunteers
- 133 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Malnutrition, ESRD
ProStat Supplementation in Dialysis Patients
This is a long-term, randomized, placebo-controlled, double blind clinical study of a nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition.
- Trial name
- NCT00435123
- Testing
- Nutritional Supplement ProStat 64 twice a day
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Fresenius Medical Care North America
Solid Tumor, Adult
FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies.
- Trial name
- NCT05069935
- Testing
- FT538, Cyclophosphamide, Fludarabine
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Fate Therapeutics
Anemia
A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on…
- Trial name
- NCT01342640
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 5 sites in Egypt
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Renal Insufficiency, Hepatic Insufficiency
Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine
Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to establish an appropriate dose and/or dosing…
- Trial name
- NCT02184091
- Testing
- Nevirapine
- Volunteers
- 41 people
- Sponsor
- Boehringer Ingelheim
Liver Cirrhosis
Alfapump-albumin Replacement Therapy
The study will be a single centre, open-label trial. The patients will have a diagnosis of refractory ascites and will meet specified inclusion/exclusion criteria Informed consent will be obtained from all patients.
- Trial name
- NCT02448160
- Testing
- alfapump, salt-poor Human Albumin solution
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Sequana Medical N.V.
Solid Tumours
A Phase I Topotecan Study in Subjects With Cancer and Impaired Renal Function
To determine the effect of renal impairment and prior platinum-based chemotherapy on the safety and blood levels of topotecan administered orally
- Trial name
- NCT00483860
- Testing
- Topotecan
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 59 people
- Sponsor
- GlaxoSmithKline
Diabetic Nephropathies, Primary Focal Segmental Glomerulosclerosis
Study of WAL0921 in Patients With Glomerular Kidney Diseases
This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and…
- Conditions
- Diabetic Nephropathies, Primary Focal Segmental Glomerulosclerosis, Minimal Change Disease, Primary Immunoglobulin A Nephropathy
- Trial name
- NCT06466135
- Testing
- WAL0921
- Where
- 50 sites in United States, Australia and 5 more
- Volunteers
- 96 people
- Sponsor
- Walden Biosciences
COVID-19
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
The purpose of this study is to learn about the side effects (safety) of the study medicine PF-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate COVID-19 infection in adults with severe renal impairment.
- Trial name
- NCT05487040
- Testing
- PF-07321332 (nirmatrelvir)/ritonavir
- Where
- 52 sites in United States
- Volunteers
- 15 people
- Sponsor
- Pfizer
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