HCV + to HCV - Kidney Transplant

Hepatitis C Clinical Trial

Official title:

Hepatitis C Viral Kidneys Used for Non-Viremic Recipients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04320290
• Other study ID #: 2020P000374
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 21, 2020
• Est. completion date: June 16, 2020

Study information

• Verified date: August 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 16, 2020
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Exclusion Criteria

• Confirmed HIV

• Confirmed HBV positive (surface antigen or HBV DNA positive)

• Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Direct Acting Antivirals
8 weeks of DAA treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

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