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

Mass General Brigham

Status and phase: Withdrawn; Phase 4

Conditions: Hepatitis C; Renal Failure Chronic

Treatments: Drug: Zepatier plus Sofosbuvir; Drug: Zepatier

Study type: Interventional

Funder types: Other

Identifiers

NCT03093740

2017P000301

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

HCV treatment - no viral resistance

Experimental group

Description:

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

Treatment:

Drug: Zepatier

HCV treatment - viral resistance

Experimental group

Description:

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

Treatment:

Drug: Zepatier plus Sofosbuvir