Clinical trials: End Stage Renal Failure
Kidney Transplantation, Chronic Kidney Failure
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney…
- Trial name
- BENEFIT (NCT00256750)
- Testing
- Cyclosporine (CsA), Belatacept LI (less intensive), Belatacept MI (more intensive)
- Where
- 105 sites in United States, Argentina and 19 more
- Volunteers
- 738 people
- Sponsor
- Bristol-Myers Squibb
CKD Anemia in Stable Dialysis Patients
Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis
The primary objective of this study is to evaluate the efficacy and safety of roxadustat compared with active control (epoetin alfa) for the maintenance treatment of anemia in participants with ESRD on dialysis.
- Trial name
- NCT02273726
- Testing
- Epoetin Alfa, Roxadustat
- Where
- 76 sites in United States, Puerto Rico
- Volunteers
- 741 people
- Sponsor
- Kyntra Bio
End-Stage Renal Disease, Hemodialysis
Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered approximately 1 to 2 hours following hemodialysis.
- Trial name
- NCT01710020
- Testing
- CP-690,550
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Pfizer
Secondary Hyperparathyroidism, End Stage Kidney Disease
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2
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-2 (NCT05836220)
- Testing
- PLS240, Open-Label Extension PLS240
- Where
- 68 sites in United States, Bulgaria and 4 more
- Volunteers
- 412 people
- Sponsor
- Pathalys Pharma
CKD Anemia in Dialysis Participants
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period.
- Trial name
- NCT04059913
- Testing
- Roxadustat
- Where
- 25 sites in China
- Volunteers
- 318 people
- Sponsor
- Kyntra Bio
Renal Failure, End Stage Renal Disease
Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane
The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone…
- Trial name
- eMPORA (NCT03315624)
- Testing
- Dialyzer
- Where
- Germany
- Volunteers
- 49 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
End Stage Renal Disease
Plazomicin Study in ESRD Patients Receiving IHD
This study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD.
- Trial name
- NCT04699656
- Testing
- Plazomicin Injection
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Cipla USA Inc.
Chronic Kidney Disease, Secondary Hyperparathyroidism
Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Hemodialysis
- Trial name
- IMPACT SHPT (NCT00977080)
- Testing
- Paricalcitol, Cinacalcet
- Where
- 83 sites in United States, Czechia and 10 more
- Volunteers
- 272 people
- Sponsor
- Abbott
Renal Failure, End Stage Renal Disease
Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration
The clinical investigation will be performed to generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil…
- Trial name
- comPERFORMStud (NCT04102280)
- Testing
- Dialyser
- Where
- 4 sites in Germany
- Volunteers
- 52 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
End Stage Renal Disease
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
This study will investigate the effect of co-administration of Triferic and heparin on the ability to maintain circuit anti-coagulation and iron delivery when compared to control conditions when each treatment is administered via…
- Trial name
- NCT04042324
- Testing
- Triferic, Heparin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Rockwell Medical Technologies, Inc.
End-Stage Renal Disease
A Pharmacokinetics, Pharmacodynamics and Safety Study of Single Dose of Rivaroxaban in Participants With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis
The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may change body function) of a single 15-milligram…
- Trial name
- NCT02289703
- Testing
- Rivaroxaban 15 mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
End Stage Renal Disease
Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]
The InterGraft™ Venous Anastomotic Connector provides an endovascular, minimally invasive means for attachment of an arteriovenous graft to a vein in the upper extremity.
- Trial name
- NCT02532621
- Testing
- Venous InterGraft Connector, sutured arterial anastomosis of an implanted vascular graft for hemodialysis, hemodialysis
- Where
- 10 sites in United States
- Volunteers
- 158 people
- Sponsor
- Phraxis, Inc.
Uremic Pruritus
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.
- Trial name
- NCT03998163
- Testing
- CR845 0.5 mcg/kg
- Where
- 47 sites in United States, Czechia and 2 more
- Volunteers
- 222 people
- Sponsor
- Cara Therapeutics, Inc.
Chronic Kidney Failure
Reduction of Heparin Dose in Dialysis With Evodial System
The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during…
- Trial name
- RHODES (NCT00781690)
- Testing
- Evodial hemodialysers and Evodia blood lines
- Where
- 7 sites in France, Germany and 2 more
- Volunteers
- 53 people
- Sponsor
- Vantive Health LLC
Anemia, Chronic Renal Failure
Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA
The purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red…
- Conditions
- Anemia, Chronic Renal Failure, Chronic Kidney Disease
- Trial name
- NCT00680043
- Testing
- peginesatide, Epoetin Alfa
- Where
- 11 sites in Russia
- Volunteers
- 114 people
- Sponsor
- Affymax
Uremic Pruritus
Phase 1 Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
This is a single-center clinical research study with the purpose to evaluate the safety, tolerability, and pharmacokinetics (PK) of nalbuphine HCl ER (extended release) tablets in end-stage renal disease (ESRD) patients receiving…
- Trial name
- NCT02373215
- Testing
- Nalbuphine HCL ER
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Trevi Therapeutics
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.
Chronic Kidney Diseases, Chronic Kidney Failure
SelfWrap-Assisted Arteriovenous Fistulas
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs).
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease, End Stage Kidney Disease
- Trial name
- SW-AVF (NCT05418816)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- VenoStent
Hepatitis C, Chronic
A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment
This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and…
- Trial name
- NCT02864199
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- 17 sites in United States, Brazil and 3 more
- Volunteers
- 63 people
- Sponsor
- Hoffmann-La Roche
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