Clinical trials: Renal Dysfunction
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in reducing elevated intact parathyroid hormone (iPTH)…
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT02282813
- Testing
- CTAP101 Capsules, Calcitriol, Doxercalciferol
- Volunteers
- 298 people
- Sponsor
- OPKO Health, Inc.
End Stage Renal Disease
Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence
Patients in renal failure on hemodialysis depend on adequate and sustained vascular access. This can be achieved by surgical placement of a synthetic polytetrafluoroethylene (PTFE) graft.
- Trial name
- AdV-VANTAGE (NCT00895479)
- Testing
- Graft placement surgery plus Trinam therapy
- Where
- 12 sites in United States
- Volunteers
- 250 people
- Sponsor
- Ark Therapeutics Ltd
End Stage Renal Disease (ESRD)
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
Randomized, cross-over, controlled, open label study. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal PD solution for long dwell exchange.
- Trial name
- NCT04086212
- Testing
- Icodextrin, xylitol and carnitine solution for peritoneal dialysis, EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution
- Sponsor
- Iperboreal Pharma Srl
Kidney Failure, Chronic
A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis
This is a multi-center, two-part study; Part A and Part B. Part A of the study is an open-label, single-dose pharmacokinetic (PK) evaluation of 100 mg RVX000222 on dialysis and non-dialysis days in eight (8) End Stage Renal…
- Trial name
- NCT03160430
- Testing
- apabetalone
- Volunteers
- 44 people
- Sponsor
- Resverlogix Corp
Fabry Disease
Safety and Pharmacokinetics of AT1001 (Migalastat HCl) in Healthy Subjects and Subjects With Impaired Renal Function
This study will assess the safety, tolerability, and pharmacokinetics (PK) study of a single dose of 150 mg AT1001 (migalastat HCl, GR181413A) administered orally to healthy subjects with normal renal function and to subjects…
- Trial name
- NCT01730469
- Testing
- AT1001 150 mg
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amicus Therapeutics
Renal Impairment
Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419
The study is a two-center, Phase 1, open-label, single-dose, one-period, four groups, PK study in subjects with various severities of renal impairment and matched healthy controls.
- Trial name
- NCT05412472
- Testing
- GC4419
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Galera Therapeutics, Inc.
Elective Cardiac Surgery
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus treatment with the CytoSorb® device.
- Trial name
- REFRESH II-AKI (NCT03384875)
- Testing
- CytoSorb
- Where
- 20 sites in United States
- Volunteers
- 186 people
- Sponsor
- CytoSorbents, Inc
Insomnia
Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)
This study will investigate whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function are similar to those observed in healthy participants; and…
- Trial name
- NCT01059851
- Testing
- Suvorexant
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Uremic Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session.
- Trial name
- NCT03422653
- Testing
- CR845 0.5 mcg/kg
- Where
- 57 sites in United States
- Volunteers
- 378 people
- Sponsor
- Cara Therapeutics, Inc.
End Stage Renal Disease
Triferic Pediatric Pharmacokinetic Protocol
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD).
- Trial name
- NCT02595437
- Testing
- Triferic
- Where
- 9 sites in United States
- Volunteers
- 22 people
- Sponsor
- Rockwell Medical Technologies, Inc.
End Stage Renal Disease, Renal Impairment
A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)
The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD)…
- Trial name
- NCT04994522
- Testing
- Belzutifan
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hyperkalemia, Heart Failure
Evaluation of Patiromer in Heart Failure Patients
The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.
- Trial name
- PEARL-HF (NCT00868439)
- Testing
- patiromer
- Where
- 33 sites in United States, Czechia and 5 more
- Volunteers
- 120 people
- Sponsor
- Relypsa, Inc.
Renal Insufficiency
Renal Safety Evaluation After Dotarem®-Enhanced MRI
Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial.
- Trial name
- RESCUE (NCT00650845)
- Testing
- Dotarem®-enhanced MRI, non-enhanced MRI
- Where
- 15 sites in Belgium, France and 2 more
- Volunteers
- 135 people
- Sponsor
- Guerbet
Diabetes Mellitus, Type 2
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin.
- Trial name
- NCT01098539
- Testing
- albiglutide, sitagliptin
- Where
- 218 sites in United States, Australia and 13 more
- Volunteers
- 507 people
- Sponsor
- GlaxoSmithKline
Acute Kidney Injury, Renal Insufficiency
A Methodological Study to Learn More About Kidney Function in Healthy People and in People With Reduced Kidney Function
The main purpose of this study is to investigate how reliable a test assessing the renal functional reserve (RFR) and the maximum glomerular filtration rate (maxGFR) are.
- Trial name
- NCT07368712
- Testing
- No investigational study intervention
- Where
- Germany
- Volunteers
- 58 people
- Sponsor
- Bayer
Hyperkalemia, Renal Insufficiency, Chronic
Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects
This is a multicentre, 2-part, single-blind, randomised, withdrawal, placebo-controlled study, that includes a 4-week patiromer treatment phase (Part A) followed by an 8-week randomised placebo-controlled withdrawal phase (Part…
- Trial name
- Patiromer JADE (NCT05136664)
- Testing
- Patiromer Powder for Oral Suspension (Part A), Patiromer Powder for Orals Suspension (Part B)
- Where
- 28 sites in China
- Volunteers
- 262 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
Chronic Kidney Disease
A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes…
- Trial name
- NCT06717698
- Testing
- NNC0519-0130, Semaglutide
- Where
- 147 sites in United States, Argentina and 12 more
- Volunteers
- 465 people
- Sponsor
- Novo Nordisk A/S
Hepatic Impairment, Renal Impairment
A Study to Assess Zibotentan Pharmacokinetics in Participants With Moderate Hepatic and Moderate Renal Impairment
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of zibotentan in patients with moderate hepatic and moderate renal impairment in comparison to a matched healthy control group.
- Trial name
- NCT05112419
- Testing
- Zibotentan
- Where
- Bulgaria
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
Disseminated Intravascular Coagulation
Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment
To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation.
- Trial name
- NCT01704001
- Testing
- ART-123
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Asahi Kasei Therapeutics Corporation