Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

• Status: Withdrawn
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

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

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Antiviral Agents; Elbasvir-grazoprevir drug combination; Sofosbuvir

Criteria

Inclusion Criteria:

• Donor meets MGH transplant center criteria and already listed for isolated kidney transplant

• No available living kidney donor

• Recipient has ≤ 730 days of accrued transplant waiting time

• Recipient chronic hemodialysis or peritoneal dialysis

• Recipient must agree to birth control.

°.Weigh ≥ 50kg

• Serum ALT within normal limits

• Subject's Insurance company approves payment for DAA therapy post-kidney transplant

Exclusion Criteria:

• AB Blood type

• HCV genotype 1

• BMI > 35

• Any liver disease in recipient

• Pregnant or nursing (lactating) women

• Known allergy or intolerance to tacrolimus that would require administration of cyclosporine

• Albumin < 3g/dl or

• Platelet count < 75 x 103/mL

• Positive crossmatch or positive donor specific antibodies

• HCV RNA positive

• Hepatitis B surface antigen positive

• Patients with primary focal segmental glomerulosclerosis (FSGS)

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