Clinical trials: End-stage Disease
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.
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.
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
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
End Stage Liver Disease
Monitoring of Symptoms and Cognitive Function Using Telehealth
End-Stage Liver Disease (ESLD) is one of the ten leading causes of death in US. It is marked by episodic acute exacerbations of the underlying liver disease which often leads to severe symptoms, poor quality of life, mental…
- Trial name
- NCT03184701
- Testing
- Telehealth
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Albert Einstein Healthcare Network
HIV-1 Infection
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1)…
- Trial name
- NCT02600819
- Testing
- E/C/F/TAF, B/F/TAF
- Where
- 26 sites in United States, Austria and 2 more
- Volunteers
- 55 people
- Sponsor
- Gilead Sciences
End Stage Renal Disease on Hemodialysis (Diagnosis)
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
- Trial name
- NCT03934736
- Testing
- HEPLISAV-B®
- Where
- 20 sites in United States
- Volunteers
- 119 people
- Sponsor
- Dynavax Technologies Corporation
End Stage Renal Failure, Hemodialysis Access Failure
Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas
An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and…
- Conditions
- End Stage Renal Failure, Hemodialysis Access Failure, Arterio-venous Fistula
- Trial name
- NCT04376567
- Testing
- One stage approach
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Tze-Woei Tan
Parathyroid Hormone
Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis
This is the post-marketing study conducted in two countries: Croatia and Serbia. In both countries Zemplar (paricalcitol) is the first injectable form of any Vitamin D Receptor (VDR) activator available for chronic kidney disease…
- Trial name
- NCT01084538
- Testing
- Zemplar iv (paricalcitol iv)
- Where
- 21 sites in Croatia, Serbia
- Volunteers
- 181 people
- Sponsor
- Abbott
CML
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation
To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5
- Trial name
- ENESTgoal (NCT01744665)
- Testing
- nilotinib
- Where
- 54 sites in United States
- Volunteers
- 59 people
- Sponsor
- Novartis Pharmaceuticals