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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03093740

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Failure Chronic Hepatitis C	Drug: Zepatier Drug: Zepatier plus Sofosbuvir	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Based on the genotype and viral resistance testing of the donor, that will be determined within the first week, we will initiate a genotype specific regimen for HCV treatment as available by prescriptionBased on the genotype and viral resistance testing of the donor, that will be determined within the first week, we will initiate a genotype specific regimen for HCV treatment as available by prescription

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient

Anticipated Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HCV treatment - no viral resistance 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	Drug: Zepatier Based on negative viral resistance testing of the donor treatment will be Zepatier
Experimental: HCV treatment - viral resistance 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	Drug: Zepatier plus Sofosbuvir Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir

Arm

Intervention/Treatment

Experimental: HCV treatment - no viral resistance

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

Drug: Zepatier

Based on negative viral resistance testing of the donor treatment will be Zepatier

Experimental: HCV treatment - viral resistance

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

Drug: Zepatier plus Sofosbuvir

Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir

Outcome Measures

Primary Outcome Measures

Undetectable HCV RNA [12 weeks post treatment]
Negative HCV viral load 12 weeks after last dose of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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