HCV + to HCV - Kidney Transplant

Phase 4

Withdrawn

• Conditions: Kidney Failure; Hepatitis C
• Interventions: Drug: Direct Acting Antivirals

• Registration Number: NCT04320290
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

The goal of this study is to determine if 8 weeks of preemptive and sustained administration of pan-genotypic DAA therapy after kidney transplant prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor kidney to an HCV-naive recipient.

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Study Start: 2020-05-21
• Primary Completion: 2020-06-16
• Study Completion: 2020-06-16
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Direct Acting Antiviral for HCV	Direct Acting Antivirals	8 weeks of treatment with HCV Direct Acting Antiviral tablet

Primary Outcome Measures

Name	Time	Method
Undetectable HCV RNA	12 weeks post-treatment	Negative HCV RNA 12 weeks after last dose of treatment
Rate of Serious and non-serious adverse events	1 year post-transplant	Determine safety of HCV+ to HCV- kidney transplantation by determining rate of adverse events related to HCV viremia or DAA treatment