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

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03093740

Enrollment

Registered

2017-03-28

Start date

2018-10-01

Completion date

2021-01-31

Last updated

2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure Chronic, Hepatitis C

Keywords

hemodialysis, renal failure, kidney transplant

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.

Interventions

DRUGZepatier

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

DRUGZepatier plus Sofosbuvir

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

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 prescription

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Undetectable HCV RNA	12 weeks post treatment	Negative HCV viral load 12 weeks after last dose of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026