The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients (NCT03809533) | Clinical Trial Compass
Active — Not RecruitingPhase 2
The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients
United States30 participantsStarted 2019-05-29
Plain-language 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+) donors to HCV seronegative recipients on the kidney transplant waitlist. Treatment and prophylaxis will be administered using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.