ESRD Clinical Trial
Official title:
A Single-center Pilot Study Evaluating a Preemptive Short Course of Glecaprevir/Pibrentasvir in Hepatitis C Positive to Negative Kidney Transplantation
The purpose of this research study is to evaluate the feasibility of a 2 week course of glecaprevir/pibrentasvir (Mavyret) starting immediately prior to transplantation to treat hepatitis C virus (HCV) in kidney transplant recipients who receive a kidney from a donor with HCV.
This is a prospective, open-label, single-center, pilot study. The patient population will include 20 patients who are on the kidney transplant waitlist at NYU Langone Health, are hepatitis C virus (HCV) negative, are willing to accept an organ from an HCV positive donor, and consent to participate in this trial. Study subjects will receive a kidney transplant from a deceased donor who tested positive for HCV as confirmed by nucleic acid amplification testing (NAT) per standard of care. All study subjects will receive a two week course of preemptive therapy with glecaprevir/pibrentasvir (Mavyret®), starting on postoperative day (POD) 0 prior to the transplant. If HCV RNA is undetectable after 2 weeks of therapy, Mavyret will be discontinued and study subjects will be followed with an intensive HCV monitoring protocol. If HCV RNA is detectable after 2 weeks of therapy, Mavyret will be continued to complete a full course of 8 weeks per standard of care. All patients will undergo close monitoring and surveillance for HCV viremia post-transplant to ensure that sustained virologic response (SVR) is achieved. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03246984 -
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
|
N/A | |
| Completed |
NCT03943212 -
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis
|
N/A | |
| Completed |
NCT03456648 -
Apixaban in End-stage Kidney Disease : A Pharmacokinetics Study
|
Phase 2 | |
| Completed |
NCT01252771 -
Phosphate Kinetic Modeling 2
|
Phase 4 | |
| Completed |
NCT00966615 -
The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition
|
Phase 4 | |
| Completed |
NCT00850252 -
Use of a Lifeline Graft in the A-V Shunt Model
|
Phase 1/Phase 2 | |
| Completed |
NCT00294502 -
Antibiotic Lock Solutions in the Prevention of Catheter Related Bacteremia
|
Phase 4 | |
| Completed |
NCT05011136 -
Physician Reimbursement Home Patients
|
||
| Completed |
NCT05144971 -
StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation
|
||
| Completed |
NCT02278562 -
Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2
|
Phase 2 | |
| Completed |
NCT01424787 -
Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)
|
N/A | |
| Terminated |
NCT00580762 -
Bariatric Surgery for ESRD Patients vs Control
|
N/A | |
| Recruiting |
NCT05339139 -
SAfety of Regional Citrate Anticoagulation (SARCA Study)
|
Phase 3 | |
| Completed |
NCT03242343 -
VasQ External Support for Arteriovenous Fistula
|
N/A | |
| Recruiting |
NCT05309785 -
Safety and Efficacy of Canagliflozin in Advanced CKD
|
Phase 4 | |
| Completed |
NCT02966028 -
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
|
Phase 2 | |
| Completed |
NCT02513303 -
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
|
Phase 3 | |
| Not yet recruiting |
NCT02596386 -
Examination of Potassium Levels in Saliva in ESRD Patients
|
N/A | |
| Active, not recruiting |
NCT02270515 -
Bringing Care to Patients: Patient-Centered Medical Home for Kidney Disease
|
N/A | |
| Recruiting |
NCT06001827 -
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
|
N/A |