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

• Status: Completed
• Trial end date: 2020-03-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Grazoprevir

Criteria

Inclusion Criteria:

1. Must meet Massachusetts General Hospital (MGH) transplant center criteria and already be listed for isolated kidney transplant

2. No available living kidney donor

3. Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.

4. On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate <15mL/min/1.73m2 at the time of screening

5. Weight ≥ 50kg

6. Serum alanine transaminase (ALT) within normal limits

Exclusion Criteria:

1. AB blood type

2. Body mass index (BMI > 35

3. History of liver disease

4. Pregnant or nursing (lactating) women

5. Cardiomyopathy (LV ejection fraction < 50%)

6. Positive crossmatch or positive donor specific antibodies

7. Human immunodeficiency virus (HIV) positive

8. Hepatitis C virus (HCV) RNA positive

9. Hepatitis B virus (HBV) surface antigen positive

10. Any contraindication to kidney transplant per MGH center protocol