Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access

• Status: Withdrawn
• Trial end date: 2021-08-04
• Target enrollment: 0
• Participant gender: Female

Summary

This is a single patient, single center study evaluating if administration of pan-genotypic DAA therapy on day 3 (+/- 2 days) post-kidney transplant prevents the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

Donor Inclusion Criteria:

• Detectable HCV Antibody Positivity

• KDPI score is less than ≤ 0.650

• Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation at MGH

Donor exclusion criteria

• Donor has been known to have previously received and failed HCV treatment with a direct-acting antiviral agent

• Confirmed HIV

• Confirmed HBV positive (surface antigen or HBV DNA positive)

• Kidney anatomical damage or significant pathology noted during recovery

• Significant liver disease or signs of liver decompensation (splenomegaly, ascites) noted during recovery (advanced fibrosis or cirrhosis)

• Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection)

Recipient Inclusion/Exclusion Criteria

• Previously enrolled in IRB 2016P002051 and experienced primary graft nonfunction due to renal vein thrombosis and acute thrombotic microangiopathy

• Willing and able to sign informed consent