Clinical trials: End Stage Disease
End Stage Renal Disease
Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis to Determine Non-inferiority of the Theranova Dialyzer Compared to the FX80 Dialyzer
In China, the estimated prevalence of patients with ESRD receiving peritoneal dialysis (PD) or maintenance hemodialysis (HD) increased from 51.7 per million population (pmp) at the end of 2007 to 79.1 pmp at the end of 2008.
- Trial name
- NCT03547323
- Testing
- Theranova 400 Dialyzer, FX80 Dialyzer
- Where
- 4 sites in China
- Volunteers
- 156 people
- Sponsor
- Vantive Health LLC
Kidney Failure
Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients
Studies have shown that patients with ESRD on hemodialysis have high levels of inflammatory markers which may contribute to the high rates of cardiovascular disease and mortality seen in these patients.
- Trial name
- NCT00294866
- Testing
- Paricalcitol
- Where
- 6 sites in United States
- Volunteers
- 64 people
- Sponsor
- Fresenius Medical Care North America
End-stage Heart Failure, Cardiomyopathies
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.
- Trial name
- NCT00483197
- Testing
- VentrAssistTM Left Ventricular Assist Device
- Where
- 29 sites in United States
- Volunteers
- 140 people
- Sponsor
- Ventracor
End-stage Renal Disease
Ellipsys Vascular Access System Registry
Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a…
- Trial name
- NCT03454113
- Testing
- Ellipsys Vascular Access
- Where
- 5 sites in Germany
- Volunteers
- 17 people
- Sponsor
- Medtronic Endovascular
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 (ESRD)
Automated Setting of Individualized Sodium Technology
The ASIST study is a medical device study testing the safety and efficacy of a new hemodialysis machine software in chronic haemodialysis patients.
- Trial name
- ASIST (NCT02795286)
- Testing
- Artis Haemodialysis Machine w/ ASIST Software - Isonatremic, Artis Haemodialysis Machine w/ ASIST Software - Isotonic, Artis Haemodialysis Machine w/o ASIST Software
- Where
- Sweden
- Volunteers
- 18 people
- Sponsor
- Vantive Health LLC
End Stage Renal Disease
Evaluation of STARgraft-2 for Hemodialysis Access
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft.
- Trial name
- NCT04783779
- Testing
- Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- Healionics Corporation
Renal Impairment
Comparing the Pharmacokinetics, Safety and Tolerability of NVA237 in Renal Impairment
The purpose of this study is to see how the body processes and gets rid of NVA237 in people who have impaired kidney function compared to people whose kidney function is normal.
- Trial name
- NCT01613690
- Testing
- NVA237
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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 Kidney Disease
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo.
- Trial name
- POSIBIL6ESKD (NCT05485961)
- Testing
- CSL300
- Where
- 566 sites in United States, Argentina and 33 more
- Volunteers
- 3,110 people
- Sponsor
- CSL Behring
Vascular Diseases, End Stage Renal Disease on Dialysis
Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular Disease and Dialysis Access
Individual patient expanded access requests may be considered for patients who have no other treatment options and are not eligible for an ATEV clinical study.
- Trial name
- NCT07141641
- Testing
- Acellular Tissue Engineered Vessel (ATEV)
- Sponsor
- Humacyte, Inc.
Gestational Trophoblastic Neoplasia, Choriocarcinoma
Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)
The purpose of the study is to determine the overall response rate of single agent TRC105 and the combination of TRC105 and bevacizumab in patients with refractory GTN (including choriocarcinoma, placental site trophoblastic…
- Conditions
- Gestational Trophoblastic Neoplasia, Choriocarcinoma, Placental Site Trophoblastic Tumor, Epithelioid Trophoblastic Tumor
- Trial name
- NCT02664961
- Testing
- TRC105, Bevacizumab
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Tracon Pharmaceuticals Inc.
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.
End Stage Renal Disease
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized…
- Trial name
- NCT06516653
- Testing
- VasQ, Arteriovenous fistula creation for dialysis vascular access
- Where
- 13 sites in United States
- Volunteers
- 300 people
- Sponsor
- Laminate Medical Technologies
Vascular Access, End Stage Renal Disease
A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas
This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and…
- Trial name
- NCT02112669
- Testing
- VasQ
- Where
- 4 sites in Israel, United Kingdom
- Volunteers
- 60 people
- Sponsor
- Laminate Medical Technologies
End Stage Renal Disease, Hemodialysis Access Failure
PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices.
- Trial name
- PReSeRVE-HD (NCT06422871)
- Testing
- HeRO® Graft System or Super HeRO® System
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Merit Medical Systems, Inc.
End Stage Renal Disease
A Multi-Centered, Two-Arm, Randomized Study Comparing the Effects of AAT-023 (Zuragen) Solution, and Heparin on the Incidence of Catheter Related Blood Stream Infections in Tunneled Chronic Central Venous Catheters for Dialysis
The purpose of this study is to determine if AAT-023 (Zuragen) solution is superior to Heparin in preventing Catheter Related Blood Stream Infections for End Stage Renal Disease patients.
- Trial name
- NCT00628680
- Testing
- AAT-023 solution (Zuragen), Heparin
- Where
- 22 sites in United States
- Volunteers
- 415 people
- Sponsor
- Ash Access Technology
Hyperphosphatemia
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
- Trial name
- NCT06664125
- Testing
- JMKX003002 will be administered orally, Sevelamer carbonate
- Where
- 2 sites in China
- Volunteers
- 50 people
- Sponsor
- Jemincare
Renal Disease, End Stage, Kidney Disease, End-Stage
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.
- Conditions
- Renal Disease, End Stage, Kidney Disease, End-Stage, AV Fistula, Fistulas Arteriovenous
- Trial name
- NCT04484220
- Testing
- Ellipsys Vascular Access System
- Where
- 12 sites in United States
- Volunteers
- 142 people
- Sponsor
- Medtronic Endovascular
Uremic Pruritus
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients…
- Trial name
- NCT05031546
- Testing
- Difelikefalin
- Sponsor
- Cara Therapeutics, Inc.