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

NCT ID: NCT03623568

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2021-04-15

Brief 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.

Detailed Description

The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after kidney transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV positive donor kidney to an HCV naïve recipient.

Conditions

Kidney Failure; Kidney Diseases; Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV

12 weeks of treatment with Mavyret

Group Type: EXPERIMENTAL

glecaprevir/pibrentasvir tablets

Intervention Type: DRUG

12 weeks of treatment with Mavyret

Interventions

glecaprevir/pibrentasvir tablets

12 weeks of treatment with Mavyret

Intervention Type: DRUG

Other Intervention Names

Mavyret

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Raymond T. Chung, MD

OTHER

Sponsor Role: lead

Responsible Party

Raymond T. Chung, MD

Director of Hepatology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Raymond T Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2018P001077

Identifier Type: -

Identifier Source: org_study_id