Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant

Description

Proof of concept, open-label single center study for the donation of HCV positive kidneys to HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Study Start Date

February, 01 2017

Estimated Completion Date

December 2020

Interventions

  • Drug: grazoprevir plus elbasvir (fixed dose combination)

Study ID

Massachusetts General Hospital -- 2016P002051

Status

Recruiting

Trial ID

NCT02945150

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

11

Sponsor

Massachusetts General Hospital

Inclusion Criteria

    1. Must meet MGH transplant center criteria and already be listed for isolated kidney transplant 2. No available living kidney donor 3. Patient has ? 548 days of accrued transplant waiting time 4. Patient on chronic hemodialysis or peritoneal dialysis 5. Weight ? 50kg 6. Serum ALT within normal limits

Exclusion Criteria

    1. AB blood type 2. BMI > 30 3. History of liver disease 4. Pregnant or nursing (lactating) women 5. Cardiomyopathy or pulmonary hypertension 6. Positive crossmatch or positive donor specific antibodies 7. HIV positive 8. HCV RNA positive 9. HBV surface antigen positive 10. Any contraindication to kidney transplant per MGH center protocol

Gender

All

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Donald Chute BA None LiverResearchGroup@partners.org

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