Clinical trials: Renal Insufficiency
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
Secondary Hyperparathyroidism, End-stage Kidney Disease (ESKD)
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1
This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases.
- Trial name
- PATH-1 (NCT05832931)
- Testing
- PLS240, Open-Label Extension PLS240
- Where
- 68 sites in United States, Bulgaria and 4 more
- Volunteers
- 362 people
- Sponsor
- Pathalys Pharma
Chronic Kidney Disease
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney…
- Trial name
- NCT00858637
- Testing
- MCI-196, Simvastatin
- Where
- 39 sites in Belarus, Bulgaria and 11 more
- Volunteers
- 260 people
- Sponsor
- Tanabe Pharma Corporation
Renally Impaired Subjects
Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects
This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with normal renal function, recruited as 1:1…
- Trial name
- NCT02313103
- Testing
- lofexidine HCl
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure
Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia
This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active comparator-controlled study has been designed to measure the palatability and preference of Lokelma® versus Veltassa® versus S/CPS in…
- Trial name
- APPETIZE (NCT04566653)
- Testing
- Calcium Polystyrene Sulphonate 15g/60 mL water, Lokelma® 5 g/45mL water, Lokelma® 10 g/45 mL water
- Where
- 18 sites in United States, Canada and 4 more
- Volunteers
- 147 people
- Sponsor
- AstraZeneca
Type 2 Diabetes Mellitus, Healthy
Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.
- Trial name
- NCT01369602
- Testing
- PF-04991532
- Where
- 2 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Pfizer
Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal
Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA)
Pre-market, single-arm, prospective, open-label, multi-center clinical trial aimed at assessing the safety and the performance of the Medyria TrackCath system in patients undergoing endovascular intervention.
- Conditions
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal, Acute Renal Failure, Acute Kidney Injury
- Trial name
- ACCESS (NCT04190979)
- Testing
- Medyria TrackCath System
- Where
- 4 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Medyria AG
Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
Pharmacokinetic and Pharmacodynamic Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes
This study is to evaluate the pharmacokinetics and pharmacodynamics of bardoxolone methyl in patients with chronic kidney disease and type 2 diabetes.
- Trial name
- NCT01549769
- Testing
- Bardoxolone Methyl
- Volunteers
- 24 people
- Sponsor
- Biogen
Healthy Volunteer, Renal Impairment
Study of AT-527 in Subjects With Normal and Impaired Renal Function
Study of AT-527 in Subjects with Normal and Impaired Renal Function
- Trial name
- NCT05618314
- Testing
- AT-527, AT-527 and Probenecid
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
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
Diabetic Kidney Disease, Diabetes Type 2
Biorepository of Biospecimen Samples in Matched Healthy Control Participants and Participants Diagnosed With Diabetic Kidney Disease, Chronic Kidney Disease, or Type 2 Diabetes
The Investigators will generate a repository of human biosamples across therapeutic areas that will be used to identify disease-associated biomarkers and potential targets with immune and multi-omics profiling.
- Conditions
- Diabetic Kidney Disease, Diabetes Type 2, Chronic Kidney Diseases, Healthy
- Trial name
- SAN-08961 (NCT05631119)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Sanguine Biosciences
Kidney Impairment
A Study of RAY1225 in Participants With Impaired Kidney Function
The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.
- Trial name
- NCT06613763
- Testing
- RAY1225
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Chronic Renal Failure With Hemodialysis
Study of rESP Injection for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis
A phase 2, randomized, open label, active comparator parallel controlled study to explore the dosage regiment of rESP, and evaluate its efficacy, safety and pharmacokinetic characteristics in the treatment of anemia in chronic…
- Trial name
- NCT03950687
- Testing
- Recombinant Human Erythropoiesis Injection (CHO cell), Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Dyslipidemia
Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)
This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects.
- Trial name
- NCT01122667
- Testing
- anacetrapib
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Kidney Disease, Type 2 Diabetes Mellitus
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
This is an observational study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied.
- Trial name
- FINEROD (NCT06278207)
- Testing
- Finerenone (BAY 94-8862)
- Where
- 4 sites in United States, Germany and 2 more
- Volunteers
- 50,000 people
- Sponsor
- Bayer
Nephrogenic Systemic Fibrosis, Renal Insufficiency
Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection
The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (eGFR 30-59)…
- Trial name
- SHERLOC (NCT00811863)
- Where
- United States
- Sponsor
- Guerbet
Kidney Failure, Chronic Therapy; Hemodialysis
A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.
The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate
- Trial name
- NCT01920854
- Testing
- soluble ferric pyrophosphate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Rockwell Medical Technologies, Inc.
End-Stage Renal Disease
L-Carnitine in Peritoneal Dialysis
The development of glucose-sparing strategies able to provide an efficacious ultrafiltration profile represents one of the modern goals of peritoneal dialysis therapy.
- Trial name
- NCT00922701
- Testing
- L-carnitine
- Where
- Italy
- Volunteers
- 4 people
- Sponsor
- Iperboreal Pharma Srl
End Stage Kidney Disease
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo.
- Trial name
- POSIBIL6ESKD (NCT05485961)
- Testing
- CSL300
- Where
- 566 sites in United States, Argentina and 33 more
- Volunteers
- 3,110 people
- Sponsor
- CSL Behring
Healthy, Renal Insufficiency
Study Assessing PK and Safety of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
This study is being conducted in healthy subjects and in subjects with a mild or moderate decrease in GFR (subjects with renal impairment).
- Trial name
- NCT04154670
- Testing
- MGTA-145
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Ensoma
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