Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant

• Status: Withdrawn
• Trial end date: 2021-04-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

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

Details

• Lead Sponsor: Raymond T. Chung, MD
• Treatments: Antiviral Agents

Criteria

Inclusion Criteria:

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

• No available living kidney donor

• 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.

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

• 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

• Weigh at least 50kg

• Serum ALT within normal limits with no history of liver disease

• Able to sign informed consent

Exclusion Criteria:

• AB blood type

• BMI > 35

• Any liver disease in recipient

• Pregnant or nursing (lactating) women

• Known allergy or intolerance to tacrolimus that would require administration of cyclosporine rather than tacrolimus given the known drug-drug interaction between cyclosporine and Mavyret

• Cardiomyopathy (LV ejection fraction < 50%)

• Albumin < 3g/dl or platelet count < 75 x 103/mL

• Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist

• Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist

• HCV RNA positive

• Hepatitis B surface antigen positive

• Any known liver disease or elevated liver transaminases

• Patients with primary focal segmental glomerulosclerosis (FSGS), FSGS recurring after previous transplant, or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or the investigator team

• Any contra-indication to kidney transplantation per MGH center protocol

• Patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.