Clinical trials: End Stage Renal Failure
End Stage Renal Disease
Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours
- Trial name
- NCT04409132
- Testing
- Triferic
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Chronic Kidney Disease, Chronic Renal Failure
A Phase 3 Study Comparing the Effects of Intravenous 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 IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose requirements in patients treated for anemia associated…
- Trial name
- AiME - 01 (NCT01473407)
- Testing
- Epoetin Hospira, Epogen (Amgen)
- Where
- 85 sites in United States, Puerto Rico
- Volunteers
- 612 people
- Sponsor
- Pfizer
ESRD, Hemodialysis
The Evaluation of the DIMI RRT System In-Center to Demonstrate Safety and Usability in the Home Environment
This is a prospective, multicenter, open label, non-randomized, cross-over study. Subjects will be enrolled in the trial for approximately 18 weeks and will use the DIMI RRT System for their dialysis treatments for all study…
- Trial name
- NCT04868643
- Testing
- The DIMI Renal Replacement Therapy (RRT) System
- Sponsor
- Dialco Medical Inc.
Chronic Kidney Diseases, Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD)…
- Trial name
- NCT03617536
- Testing
- CR845 0.25 mg Oral Tablet, CR845 0.5 mg Oral Tablet, CR845 1 mg Oral Tablet
- Where
- 60 sites in United States
- Volunteers
- 269 people
- Sponsor
- Cara Therapeutics, Inc.
Renal Disease, End Stage
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease.
- Trial name
- NCT04849650
- Testing
- Amisulpride IV, Amisulpride Oral Tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
End Stage Renal Disease (ESRD)
To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
The goal of this clinical trial is to compare the number of catheter-free days (CFD) and the rate and severity of any dialysis access-related infections between the ATEV and AVF groups over 12 months in patients with end-stage…
- Trial name
- NCT05908084
- Testing
- Acellular Tissue Engineered Vessel (ATEV), AVF
- Where
- 32 sites in United States
- Volunteers
- 121 people
- Sponsor
- Humacyte, Inc.
Kidney Transplant Rejection, End Stage Renal Disease
Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients
The purpose of this study is to evaluate the safety and tolerability of TX200-TR101 and its effects on the donated kidney in living donor kidney transplant recipients.
- Trial name
- STEADFAST (NCT04817774)
- Testing
- TX200-TR101
- Where
- 5 sites in Belgium, Netherlands and 1 more
- Volunteers
- 26 people
- Sponsor
- Sangamo Therapeutics
End Stage Renal Disease
A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With End Stage Renal Disease and Healthy Subjects
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with renal impairment and healthy subjects conducted at approximately 2 sites in the United States.
- Trial name
- NCT02135276
- Testing
- eravacycline
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Tetraphase Pharmaceuticals, Inc
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
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 Transplant Rejection, End Stage Renal Disease
Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)
This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.
- Trial name
- NCT05987527
- Testing
- Blood sample
- Where
- 5 sites in Belgium, Netherlands and 1 more
- Volunteers
- 11 people
- Sponsor
- Sangamo Therapeutics
Renal Failure, Chronic, End-Stage Renal Disease
PK of Serelaxin in Severe Renal Impairment and ESRD
The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD)…
- Trial name
- CRLX030A2102 (NCT01875523)
- Testing
- Serelaxin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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.
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
Kidney Failure,Chronic, Renal Insufficiency,Chronic
Determination In-vivo KUF for Diacap Pro Hemodialyser
The main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States.
- Conditions
- Kidney Failure,Chronic, Renal Insufficiency,Chronic, Kidney Disease, End-Stage, Kidney Insufficiency
- Trial name
- NCT02964429
- Testing
- Diacap Pro High-Flux
- Where
- Czechia
- Volunteers
- 12 people
- Sponsor
- B.Braun Avitum AG
Anemia in Chronic Kidney Disease
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis
- Trial name
- NCT01978587
- Testing
- JTZ-951
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Shionogi Inc.
PAD - Peripheral Arterial Disease, AAA - Abdominal Aortic Aneurysm
Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms, and Dialysis Access
This multicenter, single-arm retrospective registry (chart review) is being conducted to confirm the clinical performance and safety of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft throughout the device functional…
- Conditions
- PAD - Peripheral Arterial Disease, AAA - Abdominal Aortic Aneurysm, End-Stage Renal Disease
- Trial name
- NCT05124184
- Testing
- GORE® PROPATEN® Vascular Graft, GORE-TEX® Vascular Grafts
- Where
- 8 sites in France, Italy and 1 more
- Volunteers
- 356 people
- Sponsor
- W.L.Gore & Associates
End Stage Renal Disease
A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement
The ability to selectively control blood flow through an arteriovenous (AV) graft only when it is needed for dialysis may reduce the current repetitive complications such as thrombosis, venous hypertension post-dialysis bleeding…
- Trial name
- NCT01644526
- Testing
- Hemoaccess Valve System
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Diaxamed LLC
Cardiovascular Diseases, Kidney Failure, Chronic
Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.
- Trial name
- NCT01241539
- Testing
- Dabigatran etexilate
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Boehringer Ingelheim
Chronic Kidney Failure
Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line
The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.
- Trial name
- NCT00804453
- Testing
- Cartridge blood set, Standard blood line
- Where
- France
- Volunteers
- 16 people
- Sponsor
- Vantive Health LLC