Status:
WITHDRAWN
HCV + to HCV - Kidney Transplant
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Kidney Failure
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 infecti...
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) i...
Eligibility Criteria
Inclusion
- Recipient
- 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
- 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)
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04320290
Start Date
May 21 2020
End Date
June 16 2020
Last Update
August 31 2022
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