HCV + to HCV - Kidney Transplant

• Status: Withdrawn
• Trial end date: 2020-06-16
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent 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
• Treatments: Antiviral Agents

Criteria

Recipient Inclusion Criteria:

• Met MGH transplant center criteria and already listed for kidney transplant

• Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method

• No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team

• Able to sign informed consent

Recipient Exclusion Criteria:

• Pregnant or nursing (lactating) women

• HBV positivity (Ag or DNA)

• Any contra-indication to kidney transplantation per center protocol

Donor Inclusion Criteria

• Detectable HCV NAT test

• KDPI score is less than ≤ 0.850

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

Donor Exclusion Criteria

• Confirmed HIV

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

• Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)