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

Phase 4

Withdrawn

• Conditions: Renal Failure Chronic; Hepatitis C
• Interventions: Drug: Zepatier plus Sofosbuvir; Drug: Zepatier

• Registration Number: NCT03093740
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

The study objective is to determine if the administration of direct acting antivirals for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Study Start: 2018-10-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-20
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCV treatment - viral resistance	Zepatier plus Sofosbuvir	Based on the genotype and positive viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier plus Sofosbuvir
HCV treatment - no viral resistance	Zepatier	Based on the genotype and negative viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier

Primary Outcome Measures

Name	Time	Method
Undetectable HCV RNA	12 weeks post treatment	Negative HCV viral load 12 weeks after last dose of treatment

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States