HCV + to HCV - Kidney Transplant

Hepatitis C Viral Kidneys Used for Non-Viremic Recipients

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04320290

Enrollment

Registered

2020-03-24

Start date

2020-05-21

Completion date

2020-06-16

Last updated

2022-08-31

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

Conditions

Hepatitis C, Kidney Failure

Keywords

Kidney Transplant, Kidney Failure, HCV, Hepatitis C

Brief summary

This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

Detailed description

The goal of this study is to determine if 8 weeks of preemptive and sustained administration of pan-genotypic DAA therapy after kidney transplant prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor kidney to an HCV-naive recipient.

Interventions

DRUGDirect Acting Antivirals

8 weeks of DAA treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Recipient Inclusion Criteria: * Met MGH transplant center criteria and already listed for kidney transplant * 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 * No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team * Able to sign informed consent Recipient

Exclusion criteria

* Pregnant or nursing (lactating) women * HBV positivity (Ag or DNA) * Any contra-indication to kidney transplantation per center protocol Donor Inclusion Criteria * Detectable HCV NAT test * KDPI score is less than ≤ 0.850 * Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation Donor

Design outcomes

Primary

Measure	Time frame	Description
Undetectable HCV RNA	12 weeks post-treatment	Negative HCV RNA 12 weeks after last dose of treatment
Rate of Serious and non-serious adverse events	1 year post-transplant	Determine safety of HCV+ to HCV- kidney transplantation by determining rate of adverse events related to HCV viremia or DAA treatment

Outcome results

None listed

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