Clinical trials: Dialysis Patients
Chronic Renal Failure
Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in patients with chronic renal failure who are undergoing peritoneal dialysis, using daily urine volume, body weight, and edematous…
- Trial name
- NCT01895322
- Testing
- OPC-41061
- Where
- 6 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Renal Dialysis, Hemodiafiltration
Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients
Introduction: Cardiovascular disease is the leading cause of morbidity and mortality in patients undergoing hemodialysis, largely due to structural cardiac changes associated with left ventricular diastolic dysfunction.
- Conditions
- Renal Dialysis, Hemodiafiltration, Diastolic Dysfunction, Kidney Failure
- Trial name
- EXE-HDF (NCT06584734)
- Testing
- Not exercise, Exercise during hemodiafiltration session
- Where
- Mexico
- Volunteers
- 30 people
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
End Stage Renal Disease
Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients
Many children with end stage renal disease develop hyperlipidemia. HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, such as pravastatin, are typical treatments for hyperlipidemia.
- Trial name
- NCT00571194
- Testing
- pravastatin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Arkansas Children's Hospital Research Institute
Chronic Kidney Disease
Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)
Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis.
- Trial name
- EPOCH-RRT (NCT02440659)
- Where
- United States
- Volunteers
- 2,946 people, healthy volunteers welcome
- Sponsor
- Arbor Research Collaborative for Health
COVID-19
Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients
Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN® injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by the thymus gland.
- Trial name
- Ta1 (NCT04428008)
- Testing
- Thymalfasin
- Where
- United States
- Volunteers
- 189 people
- Sponsor
- William B. Ershler, MD
Complication of Dialysis
Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis
Providing hemodialysis requires the use of an extracorporeal circuit which must be anticoagulated. Inadequate anticoagulation can result in the dialyzer clotting with decreased circuit blood flows, inefficient dialysis and even…
- Trial name
- NCT01590550
- Testing
- Use of citrate based dialysate
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Loma Linda University
Cardiovascular Disease
Feasibility Study of Omega-3 Fatty Acids in Dialysis Patients
Cardiovascular disease and mortality is the largest comorbidity within the dialysis population. Nearly 50% of hemodialysis patients will have congestive heart failure at initiation.
- Trial name
- NCT01002118
- Testing
- Omega-3 Acid Ethyl Esters
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Iowa
Continuous Ambulatory Peritoneal Dialysis, End Stage Renal Disease
Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis
The objective of this study is to characterize the pharmacokinetic profile of ertapenem during continuous ambulatory peritoneal dialysis (CAPD).
- Trial name
- NCT00939952
- Testing
- ertapenem
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Albany College of Pharmacy and Health Sciences
Anemia, Chronic Kidney Disease
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
The primary objectives of this study are the following: 1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is…
- Conditions
- Anemia, Chronic Kidney Disease, Kidney Disease
- Trial name
- NCT00436748
- Testing
- Darbepoetin Alfa
- Where
- 67 sites in United States, Belgium and 8 more
- Volunteers
- 116 people
- Sponsor
- Amgen
Chronic Kidney Disease, Anemia
Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.
- Trial name
- DIAMOND (NCT01478971)
- Testing
- Epoetin, Peginesatide
- Where
- 5 sites in United States
- Volunteers
- 184 people
- Sponsor
- Takeda
Anemia Associated With End Stage Renal Disease (ESRD)
Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
The purpose of this study is to assess the safety and effectiveness of Roxadustat dosing regimens among chronic dialysis participants converted from ESA therapy or who are ESA-naïve.
- Trial name
- NCT04410198
- Testing
- Roxadustat
- Where
- 9 sites in United States
- Volunteers
- 203 people
- Sponsor
- Kyntra Bio
End-Stage Renal Disease, Stage 5 Chronic Kidney Disease
Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
Chronic Kidney Disease Stage 5 (CKD5) patients receiving maintenance hemodialysis are at an increased risk for developing bloodstream infections.
- Trial name
- NCT02392208
- Testing
- Telavancin, Pharmacokinetic Blood Sampling
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Michigan
Chronic Kidney Disease, Receiving Dialysis
Study of South African Dialysis Patients
An observational study to describe the treatment of anaemia in patients with chronic kidney disease, who are receiving dialysis treatment at selected study centres in South Africa.
- Trial name
- NCT01890577
- Testing
- Aranesp
- Where
- 7 sites in South Africa
- Volunteers
- 28 people
- Sponsor
- Amgen
Intradialytic Hypertension
Mechanisms and Treatment of Intradialytic Hypertension
1. To determine in a cross sectional case-controlled cohort study of 50 hemodialysis patients if blood pressure elevations with hemodialysis are associated with decreased endothelial cell function (measured by brachial artery…
- Trial name
- MATCH (NCT00827775)
- Testing
- Carvedilol
- Where
- 3 sites in United States
- Volunteers
- 55 people
- Sponsor
- University of Texas Southwestern Medical Center
Chronic Kidney Disease, End Stage Renal Failure on Dialysis
Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients
The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.
- Conditions
- Chronic Kidney Disease, End Stage Renal Failure on Dialysis, Anemia
- Trial name
- NCT02506868
- Testing
- Darbepoetin alfa
- Where
- 30 sites in Russia
- Volunteers
- 196 people
- Sponsor
- Biocad
Chronic Kidney Disease Requiring Chronic Dialysis
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients.
- Trial name
- NCT01324128
- Testing
- PA21 (2.5 g tablet containing 500 mg iron), Sevelamer carbonate, PA21-1 (1.25 g tablet containing 250 mg iron)
- Where
- 15 sites in United States, Austria and 13 more
- Volunteers
- 1,059 people
- Sponsor
- Vifor Pharma
Complication of Renal Dialysis, End Stage Renal Disease
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS2 (NCT05425056)
- Testing
- Sirolimus
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 136 people
- Sponsor
- Vascular Therapies, Inc.
Renal Insufficiency, Chronic, Kidney Failure, Chronic
Effect of Vitamin D Supplementation on Balance in CKD
Patients with end-stage renal disease on dialysis (ESRD5D) are 4-5x more likely to suffer from a fracture. Fractures can occur spontaneously but typically occur after a fall.
- Trial name
- NCT03710161
- Testing
- Vitamin D
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Nebraska
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
- Trial name
- NCT01439867
- Testing
- Cinacalcet hydrochloride, Standard of Care
- Where
- 42 sites in United States, Belgium and 11 more
- Volunteers
- 18 people
- Sponsor
- Amgen
Hyperphosphatemia
Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China
Primary Objective: To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in hyperphosphatemia in participants with chronic kidney disease not on dialysis.
- Trial name
- RECOVER (NCT03001011)
- Testing
- Sevelamer Carbonate (GZ419831)
- Where
- 38 sites in China
- Volunteers
- 202 people
- Sponsor
- Sanofi