Multi-center Study to Transplant Hepatitis-C Infected Kidneys

Phase 4

Completed

Brief Summary: Open label multi center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

Detailed Description: The study objective is to determine if the administration of the direct acting antiviral glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective at preventing the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Recruitment & Eligibility

Inclusion Criteria

Estimated glomerular filtration rate(eGFR) < 15 ml/min/1.73 m2
Listed for an isolated kidney transplantation
Able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent
No available medically acceptable, compatible living kidney donor
Subject must agree to use an effective method of birth control per protocol specifications

Recipient

Exclusion Criteria

History of severe, life-threatening or other significant sensitivity to immunosuppressants utilized in kidney transplant
Female who is pregnant, breastfeeding, or is planning to become pregnant during the course of the study
History of HIV
HCV RNA positive
HBV surface Ag-positive or detectable HBV DNA
Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or investigator team
Presence of clinically significant liver disease
Transplant candidate requiring antibody desensitization protocol for transplantation
Most recent calculated panel reactive antibody (cPRA) >80%.
Prior recipient of a non-renal solid organ transplant

Donor Organ Inclusion Criteria

Donor Organ Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Treatment with glecaprevir/pibrentasvir Fixed Dose Combination	glecaprevir/pibrentasvir treatment	8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir

Primary Outcome Measures

Name	Time	Method
Number of Participants With Undetectable HCV	12 weeks post treatment	HCV RNA \< LLOQ 12 weeks after the last actual dose of G/P

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With On-treatment Virologic Failure	During 8 week treatment course	HCV RNA \> LLOQ during G/P treatment
Percentage of Subjects With Post-treatment Virologic Relapse	During 12 week post treatment follow-up	HCV RNA \> LLOQ after completion of G/P treatment and prior HCV RNA \< LLOQ while on treatment

Locations (7): University of Cincinnati Medical Center
🇺🇸
Cincinnati, Ohio, United States
John Hopkins
🇺🇸
Baltimore, Maryland, United States
Northwestern Medicine
🇺🇸
Chicago, Illinois, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Weill Cornell Medical Center
🇺🇸
New York, New York, United States