End Stage Renal Disease Clinical Trial
Official title:
A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure).
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure). Following successful creation of the AV fistula, the cohort randomized to the treatment group will receive the SeCI; the control group will not receive an implant. The primary hypothesis is that the proportion of subjects that meet requirements for fistula suitability for dialysis six months following the index procedure will be higher in the treatment group in comparison to the control group. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04076488 -
Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases
|
N/A | |
| Completed |
NCT03289650 -
Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
|
Phase 3 | |
| Completed |
NCT04042324 -
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
|
Phase 1/Phase 2 | |
| Completed |
NCT01242904 -
Use of a Bimodal Solution for Peritoneal Dialysis
|
Phase 2 | |
| Active, not recruiting |
NCT03183245 -
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
|
Phase 3 | |
| Completed |
NCT03257410 -
Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
|
N/A | |
| Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
| Recruiting |
NCT05917795 -
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
|
N/A | |
| Terminated |
NCT03539861 -
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
|
N/A | |
| Withdrawn |
NCT02130817 -
Belatacept in Kidney Transplantation of Moderately Sensitized Patients
|
Phase 4 | |
| Completed |
NCT05540457 -
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)
|
N/A | |
| Not yet recruiting |
NCT04900610 -
The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis
|
N/A | |
| Recruiting |
NCT02176434 -
Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease
|
N/A | |
| Active, not recruiting |
NCT02581449 -
Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis
|
Phase 2 | |
| Completed |
NCT02832466 -
Quantifying the Deterioration of Physical Function in Renal Patients
|
N/A | |
| Completed |
NCT02832440 -
Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis
|
N/A | |
| Completed |
NCT02134314 -
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
|
Phase 1/Phase 2 | |
| Completed |
NCT02830490 -
Reliability of Functional Measures in Hemodialysis Patient.
|
N/A | |
| Completed |
NCT02215655 -
Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
|
N/A | |
| Recruiting |
NCT01912001 -
Virtual Ward for Home Dialysis
|
N/A |