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

Raymond T. Chung, MD

Status and phase

Withdrawn

Phase 4

Conditions

Kidney Failure

Kidney Diseases

Hepatitis C

Treatments

Drug: glecaprevir/pibrentasvir tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT03623568

2018P001077

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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.