Clinical trials: End Stage Renal Failure
End-stage Renal Failure
Safety and Dialysability of Dotarem® in Dialysed Patients
To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.
- Trial name
- NCT01449266
- Testing
- Dotarem® IV injection at 0.1 mmol/kg
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Guerbet
End Stage Renal Disease (ESRD)
Bayston Multicenter Antimicrobial PD Catheter Safety Study
The study was designed to establish the safety of the Bayston Antimicrobial PD catheter that is impregnated with a "cocktail" of three well known anti-microbials
- Trial name
- Bayston (NCT02274896)
- Testing
- PD Catheter group
- Where
- 5 sites in Belgium, Netherlands and 1 more
- Sponsor
- Medical Components, Inc dba MedComp
Thrombosis, Factor XI
A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment
An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants before and after a hemodialysis session to evaluate safety, tolerability, and pharmacokinetics in this patient population.
- Conditions
- Thrombosis, Factor XI, Renal Impairment, ESRD (End-Stage Renal Disease)
- Trial name
- NCT02902679
- Testing
- BMS-986177
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Bristol-Myers Squibb
Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis
Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
- Trial name
- NCT01901107
- Testing
- Kiklin capsules
- Where
- 8 sites in Japan
- Volunteers
- 1,078 people
- Sponsor
- Astellas Pharma Inc
Renal Impairment, Hemodialysis
Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis
This is a multicenter, open-label parallel-group to evaluate single oral doses of INCB000928 in participants with varying level of renal function or impairment.
- Trial name
- NCT05099445
- Testing
- INCB000928
- Where
- 5 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
End Stage Renal Disease, Peritoneal Dialysis-associated Peritonitis
A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis
This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.
- Conditions
- End Stage Renal Disease, Peritoneal Dialysis-associated Peritonitis, Peritonitis
- Trial name
- ACT (NCT05285436)
- Testing
- CloudCath System
- Where
- United States
- Volunteers
- 314 people
- Sponsor
- CloudCath
Chronic Renal Failure
A Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
To investigate the safety, pharmacokinetics, pharmacodynamics, and efficacy of OPC-41061 in patients with chronic renal failure undergoing hemodialysis or hemodiafiltration using variables, such as daily urine volume and increase…
- Trial name
- NCT01876381
- Testing
- OPC-41061
- Where
- 5 sites in Japan
- Volunteers
- 26 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Uncontrolled Hypertension
Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension
This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the MobiusHD® system in renal hemodialysis subjects with uncontrolled hypertension.
- Trial name
- HD (NCT05352425)
- Testing
- MobiusHD
- Sponsor
- Vascular Dynamics, Inc.
Pure Red-cell Aplasia
A Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa
The purpose of this study is to collect historical occurrences of risk factors that are potentially associated with the development of anti-erythropoietin (EPO) antibody positive pure red cell aplasia (PRCA) in participants with…
- Trial name
- NCT00211068
- Testing
- No intervention
- Where
- 22 sites in Brazil, France and 5 more
- Volunteers
- 124 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Secondary Hyperparathyroidism, End Stage Renal Disease
A Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving Selective Vitamin D Receptor Activator's for Prevention and Treatment of Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in the normal clinical setting and according…
- Trial name
- NCT01149291
- Where
- 22 sites in Turkey (Türkiye)
- Volunteers
- 511 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Kidney Failure, Acute Kidney Failure
Theranova Randomized, Controlled, Trial (RCT) in China
Traditional hemodialysis (HD) therapy is very effective in clearing urea and smaller middle molecules, but is limited in clearing larger middle molecules.
- Trial name
- ROCKet (NCT05309291)
- Testing
- Theranova 400 Dialyzer, FX 800 Dialyzer
- Where
- 10 sites in China
- Volunteers
- 323 people
- Sponsor
- Vantive Health LLC
Renal Impairment
Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function
Evaluation of the pharmacokinetics (PK) of TBPM-PI-HBr in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD)…
- Trial name
- NCT04178577
- Testing
- Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)
- Where
- 2 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Spero Therapeutics
Restless Legs Syndrome, End-Stage Renal Disease
A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.
- Trial name
- NCT01537042
- Testing
- Rotigotine
- Where
- 15 sites in United States, Austria and 4 more
- Volunteers
- 30 people
- Sponsor
- UCB BIOSCIENCES GmbH
Kidney Disease, End-Stage, End-stage Renal Disease
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.
- Conditions
- Kidney Disease, End-Stage, End-stage Renal Disease, Arteriovenous Fistula
- Trial name
- CONNECT-AV (NCT04634916)
- Testing
- EndoAVF Creation
- Where
- 17 sites in United States, Australia
- Volunteers
- 220 people
- Sponsor
- C. R. Bard
Chronic Renal Failure
EPO-BUL-01 - Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure
The purpose of the study is to evaluate the effectiveness, safety and clinical outcome of Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the treatment of anemia in predialysis.
- Trial name
- NCT00338000
- Testing
- Epoetin alfa
- Volunteers
- 292 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
Anemia of End Stage Renal Disease
Comparison Among Erythropoietin Stimulating Agents
Background: Despite extensive use, to the best of our knowledge, no trial has simultaneously compared the three currently used erythropoietin stimulating agents (ESAs) in a prospective manner, in treatment of anemia of end stage…
- Trial name
- NCT02049346
- Testing
- Epoetin alpha or beta (Epoetin group), Darbepoetin alfa, Methoxy polyethylene glycol-epoetin beta
- Where
- Qatar
- Volunteers
- 327 people
- Sponsor
- Hamad Medical Corporation
Chronic Kidney Failure
Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.
- Trial name
- NCT00844662
- Testing
- Fermagate, Sevelamer hydrochloride
- Where
- 109 sites in United States, Belgium and 13 more
- Volunteers
- 1,000 people
- Sponsor
- Ineos Healthcare Limited
Kidney Failure, Chronic, Renal Dialysis
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD).
- Trial name
- NCT03645681
- Testing
- InnAVasc arteriovenous graft surgical implant
- Where
- 7 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates
Hepatitis C, Chronic
HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.
- Trial name
- NCT02806505
- Testing
- Peginterferon alfa-2a
- Where
- 22 sites in Austria, Brazil and 6 more
- Volunteers
- 81 people
- Sponsor
- Hoffmann-La Roche
End Stage Renal Disease
A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis
Malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (HD) patients. The purpose of this study is to characterize the safety of GHRP-1/AG in subjects with ESRD on HD; to characterize…
- Trial name
- NCT00381602
- Testing
- GHRP-1/AG 70 mg depot in ESRD
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- QLT Inc.