Status:
ACTIVE_NOT_RECRUITING
The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients
Lead Sponsor:
Amit D Tevar, MD
Collaborating Sponsors:
University of Pittsburgh Medical Center
Conditions:
Kidney Transplantation
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) do...
Detailed Description
This is a prospective, single center, pilot, open-label study of transplantation of kidneys of HCVAb+ donors to HCVAb- recipients with subsequent therapy with sofosbuvir/velpatasvir (Epclusa®). Recipi...
Eligibility Criteria
Inclusion
- Inclusion criteria (recipients):
- Patients with end-stage renal disease listed for kidney transplantation at UPMC.
- On chronic hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate \< 15 ml/min
- Age ≥ 18
- No available living kidney donor
- Listed for an isolated kidney transplant at UPMC with \<60m of accrued transplant waiting time and/or \<60m of dialysis time
- Have panel reactive antibody level of \<98%
- No obvious contraindication to kidney transplant
- Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation
- Able to provide informed consent
- Be willing to use a contraceptive method for a year after transplant
- Exclusion criteria (recipients):
- HIV positive
- HCVAb or HCV RNA positive
- Presence of behavioral risk factors for contracting HCV other than being on hemodialysis. These behavioral risk factors are current injection drug use, current intranasal illicit drug use, current percutaneous/parenteral exposures in an unregulated setting.
- Hepatitis B surface antigen positive
- History of liver cirrhosis
- Persistently elevated liver transaminases, defined as ALT/AST at least 3 times the upper limit of normal for a minimum of 3 consecutive months
- History of atrial fibrillation requiring the use of amiodarone over the past 12m
- Patients with etiology of renal failure with increased risk of causing early graft failure as assessed by the investigator team
- Receipt of prior organ transplant
- Waitlisted for a multi-organ transplant
- Pregnant women
- Known allergy to sofosbuvir/velpatasvir
- Any condition, psychiatric or physical, that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study
- Inclusion criteria (donors):
- HCV antibody positive
- HCV NAT negative or positive
- Kidney donor profile index (KDPI) score \<85
- Exclusion criteria (donors):
- Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT)
- Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT)
- Known ongoing therapy for HCV
Exclusion
Key Trial Info
Start Date :
May 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03809533
Start Date
May 29 2019
End Date
April 1 2026
Last Update
November 6 2025
Active Locations (1)
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1
UPMC
Pittsburgh, Pennsylvania, United States, 15213