Clinical trials: Chronic End Stage Renal Failure
End Stage Renal Disease
Health Effects of oraL Protein Supplements in HD (The HELPS-HD Trial)
To conduct a pragmatic randomized clinical trial in which the researchers will determine the mortality impact of a protocol whereby all hemodialysis patients receive an oral, protein-based nutritional supplement during the…
- Trial name
- HELPS-HD (NCT02933151)
- Testing
- Nutritional Supplement
- Where
- 2 sites in United States
- Volunteers
- 10,457 people
- Sponsor
- Dialysis Clinic, Inc.
Chronic Kidney Disease, Chronic Renal Disease
Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis
The purposes of this study are to determine if the performance of a dialyzer depends on how tightly the hollow fiber membranes are packed in the housing of the dialyzer (the membrane packing density) and if that dependence is a…
- Trial name
- NCT00636077
- Testing
- Polyflux HD-C4 Big, HD-C4 Small, Optiflux 160NR
- Where
- United States
- Volunteers
- 12 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
Staphylococcus Aureus Infection
A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)
This is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.
- Trial name
- NCT00572910
- Volunteers
- 206 people
- Sponsor
- Merck Sharp & Dohme LLC
Kidney Failure, Chronic, Hemodialysis Complication
The Pristine Post-Market Study
This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristine™ Long-Term Hemodialysis Catheter.
- Conditions
- Kidney Failure, Chronic, Hemodialysis Complication, Hemodialysis Catheter Infection, Hemodialysis Access Failure
- Trial name
- NCT05228132
- Testing
- Pristine™ Long-Term Hemodialysis Catheter
- Where
- 6 sites in United States
- Volunteers
- 142 people
- Sponsor
- C. R. Bard
End Stage Renal Disease, Thrombosis
Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis
This study evaluates the safety and efficacy of AB023 (xisomab 3G3) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts.
- Trial name
- NCT03612856
- Testing
- AB023- Dose 1, AB023-Dose 2
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Aronora, Inc.
Chronic Kidney Disease, Chronic Renal Disease
Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate
The purpose of this study is to look at how the dose of dialysis is affected by the rate at which dialysate flows through the dialyzer.
- Trial name
- NCT00962000
- Testing
- Dialysis Flow Rate Start 600mL/min, Dialysis Flow Rate Start 800mL/min
- Where
- 3 sites in United States
- Volunteers
- 42 people
- Sponsor
- Vantive Health LLC
Transplant; Failure, Kidney, Renal Disease, End Stage
Oral Paricalcitol in Kidney Transplant Recipients
This study is being done to find out whether patients who receive a kidney transplant can benefit from taking the medication paricalcitol (trade name Zemplar®) as compared to kidney transplant recipients not taking this…
- Conditions
- Transplant; Failure, Kidney, Renal Disease, End Stage, Hyperparathyroidism, Secondary
- Trial name
- NCT00587158
- Testing
- Paricalcitol, Corticosteroid Avoidance Immune Suppression Protocol
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
End Stage Renal Disease, Chronic Kidney Diseases
Shared Decision Making in Dialysis
Older patients ≥65 years with chronic kidney disease (CKD) face challenges in decision making about dialysis. These patients report little effort by physicians to elicit treatment preferences, discuss prognoses, or explain the…
- Trial name
- DIAL-SDM (NCT04392440)
- Testing
- DIAL-SDM, usual care
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- University of Rochester
Chronic Renal Failure, Chronic Kidney Disease
A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients…
- Trial name
- AiME - 13 (NCT01473420)
- Testing
- Epoetin Hospira, Epogen Amgen
- Where
- 73 sites in United States
- Volunteers
- 320 people
- Sponsor
- Pfizer
Anemia
A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.
This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or…
- Trial name
- NCT00576303
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 18 sites in Russia
- Volunteers
- 200 people
- Sponsor
- Hoffmann-La Roche
Anemia, End Stage Renal Disease (ESRD)
Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin.
- Trial name
- Pyrenees (NCT02278341)
- Testing
- Roxadustat, Epoetin alfa, Darbepoetin alfa
- Where
- 143 sites in Belgium, Bulgaria and 15 more
- Volunteers
- 838 people
- Sponsor
- Astellas Pharma Europe B.V.
Diabetes, End Stage Renal Disease
Hyperglycemia in Renal Transplantation
Based on multiple prior studies, kidney transplant recipients with diabetes are at higher risk for poor initial graft function after transplant.
- Trial name
- HiRT (NCT01643382)
- Testing
- Insulin, Insulin, Asp(B28)-
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, San Francisco
Chronic Hepatitis C
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic…
- Trial name
- SOF/VEL ESRD (NCT03036852)
- Testing
- SOF/VEL
- Where
- 22 sites in Australia, Canada and 4 more
- Volunteers
- 59 people
- Sponsor
- Gilead Sciences
End Stage Renal Disease, Hepatitis C
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time.
- Trial name
- NCT03627299
- Testing
- 300mg glecaprevir/pibrentasivir 120mg
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Johns Hopkins University
End Stage Renal Disease
Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study A
The primary purpose of this study is to test the feasibility of trials which change the dialysate (dialysis bath prescription) of potassium and bicarbonate according to a standardized algorithm and according to the results of…
- Trial name
- RADAR-A (NCT03519347)
- Testing
- Potassium Removal Maximization, Potassium Gradient Minimization, Alkalosis Avoidance
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- NYU Langone Health
Kidney Failure, Chronic, End-Stage Renal Disease
Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant…
- Conditions
- Kidney Failure, Chronic, End-Stage Renal Disease, Transplant Glomerulopathy, Transplant;Failure,Kidney
- Trial name
- NCT03380962
- Testing
- Clazakizumab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stanley Jordan, MD
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy
- Trial name
- TRANSFORM (NCT01950819)
- Testing
- Induction therapy, Corticosteroids, EVR+rCNI
- Where
- 184 sites in United States, Argentina and 40 more
- Volunteers
- 2,037 people
- Sponsor
- Novartis Pharmaceuticals
Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis
Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis
The primary objectives of this study were to determine the rate, extent, and routes of radioactivity excretion of [¹⁴C]etelcalcetide in feces, dialysate, and urine over time and to measure radioactivity concentrations in whole…
- Trial name
- NCT02054572
- Testing
- [¹⁴C]Etelcalcetide
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Amgen
Anemia, Renal Failure
Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure
The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.
- Trial name
- NCT00318812
- Testing
- Heme Iron Polypeptide (Proferrin), Iron sucrose (Venofer)
- Where
- Canada
- Volunteers
- 55 people
- Sponsor
- Ottawa Hospital Research Institute