Clinical trials: Renal Impairment
Acute Kidney Injury
Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System
This study is designed to evaluate background fluorescence of participants of different ages, gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be evaluated.
- Trial name
- NCT03810833
- Testing
- Brilliance device sensor
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- MediBeacon
Peritoneal Dialysis, Chronic Kidney Disease
Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis
The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.
- Trial name
- NCT00196755
- Testing
- Sevelamer Hydrochloride (Renagel®), Calcium acetate (PhosLo® )
- Where
- 17 sites in Belgium, Denmark and 5 more
- Volunteers
- 138 people
- Sponsor
- Genzyme, a Sanofi Company
Type 2 Diabetes
Pharmacokinetic and Safety Studies of HRS-7535 in Subjects With Moderate Renal Insufficiency and Healthy Subjects
The study is being conducted to evaluate and compare the pharmacokinetics of HRS-7535 tablets in subjects with moderate renal insufficiency and healthy subjects.
- Trial name
- NCT06132204
- Testing
- HRS-7535 Tablets
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Renal Insufficiency
Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment
The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram) tablets in healthy adult volunteers and those with mild and moderate renal impairment, and examine between group comparisons.
- Trial name
- NCT01316055
- Testing
- Dalfampridine-ER
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Acorda Therapeutics
Renal Impairments
A Study to Evaluate EDG-7500 in People With Renal Impairment
The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after a single dose in participants with different levels of kidney function impairment versus participants with normal kidney…
- Trial name
- NCT07034768
- Testing
- EDG-7500
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Edgewise Therapeutics, Inc.
Anemia Associated With Chronic Kidney Disease (CKD)
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of…
- Trial name
- NCT04707768
- Testing
- Vadadustat, Mircera®
- Where
- 58 sites in United States
- Volunteers
- 456 people
- Sponsor
- Akebia Therapeutics
Diabetic Kidney Disease, Chronic Kidney Diseases
A Long-Term Follow-Up Study of Participants Exposed to REACT
The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants…
- Trial name
- NCT05918523
- Testing
- Renal Autologous Cell Therapy (REACT)
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Prokidney
Chronic Hepatitis C, Hepatitis C Virus
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis, Severe Renal Impairment
- Trial name
- NCT02207088
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, Ribavirin
- Volunteers
- 68 people
- Sponsor
- AbbVie
Hepatitis C
Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.
- Trial name
- NCT01830205
- Testing
- Daclatasvir
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- Bristol-Myers Squibb
Chronic Kidney Disease
Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
This is a multicenter, non-randomized, open-label, parallel-controlled study. The main objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild and moderate renal impairment versus healthy…
- Trial name
- NCT06039254
- Testing
- HRS-1780
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Hypercholesterolaemia
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment…
- Trial name
- NCT05934292
- Testing
- Enlicitide Decanoate
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hyperphosphatemia
Dose Finding Study to Treat High Phosphate Levels in the Blood.
Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period
- Trial name
- NCT02081534
- Testing
- AZD1722
- Where
- 41 sites in United States, Poland and 2 more
- Volunteers
- 162 people
- Sponsor
- Ardelyx
Kidney Failure, Graft Rejection
Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients
The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.
- Conditions
- Kidney Failure, Graft Rejection, Aged
- Trial name
- NCT00254709
- Testing
- Sirolimus
- Volunteers
- 66 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Chronic Kidney Disease
Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance
The purpose of this study is to investigate the safety and tolerability of LY2623091 after multiple oral dosing in healthy men and women of non-childbearing potential.
- Trial name
- NCT01237899
- Testing
- LY2623091, Eplerenone
- Where
- Netherlands
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Renal Insufficiency, Chronic
Catheter System Feasibility Clinical Trial
Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.
- Trial name
- NCT02816398
- Testing
- Percutaneous creation of an arteriovenous fistula
- Volunteers
- 26 people
- Sponsor
- Medtronic Endovascular
Renal Insufficiency
Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®
- Trial name
- NSsaFe (NCT01467271)
- Where
- 27 sites in United States, Argentina and 9 more
- Volunteers
- 540 people
- Sponsor
- Guerbet
Diabetes Mellitus, Type 2, End-Stage Kidney Disease
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)
The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who do not have adequate glycemic control.
- Trial name
- NCT00509236
- Testing
- Sitagliptin, Glipizide
- Volunteers
- 129 people
- Sponsor
- Merck Sharp & Dohme LLC
Infection, Human Immunodeficiency Virus, HIV Infections
Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment
GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development for both the treatment and prevention of human immunodeficiency virus (HIV) infection.
- Trial name
- NCT02354937
- Testing
- GSK1265744 30 mg
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- ViiV Healthcare
End Stage Renal Disease
Analysis of CRBSI Rates in Patients With a NexSite™ HD (Hemodialysis) Catheter
A U.S. multi-centre post approval registry to analyse the CRBSI rate in patients with the NexSite HD Catheter for long term vascular access for hemodialysis.
- Trial name
- NCT02453646
- Testing
- NexSite HD Patients
- Where
- 6 sites in United States
- Volunteers
- 120 people
- Sponsor
- Marvao Medical
Chronic Renal Failure
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
The purpose of this study is to evaluate the effectiveness and safety of icodextrin and glucose peritoneal dialysis (PD) solutions for the long dwell exchange in PD patients with continuous ambulatory peritoneal dialysis (CAPD)…
- Trial name
- oSCAR (NCT06492031)
- Testing
- Icodextrin Peritoneal Dialysis Solution, Glucose Peritoneal Dialysis Solution
- Where
- 10 sites in China
- Volunteers
- 439 people
- Sponsor
- Vantive Health LLC
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