HCV + to HCV - Kidney Transplant

NCT ID: NCT04320290

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-21
• Study Completion Date: 2020-06-16

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.

Conditions

Kidney Failure; Hepatitis C

Study Design

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

Study Groups

Treatment with Direct Acting Antiviral for HCV

8 weeks of treatment with HCV Direct Acting Antiviral tablet

Group Type: EXPERIMENTAL

Direct Acting Antivirals

Intervention Type: DRUG

8 weeks of DAA treatment

Interventions

Direct Acting Antivirals

8 weeks of DAA treatment

Intervention Type: DRUG

Other Intervention Names

Direct Acting Antiviral HCV Treatment

Eligibility Criteria

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

• Detectable HCV NAT test
• KDPI score is less than ≤ 0.850
• Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation

Exclusion Criteria

• Pregnant or nursing (lactating) women
• HBV positivity (Ag or DNA)
• Any contra-indication to kidney transplantation per center protocol

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nahel Elias, M.D.

Surgical Director, Kidney Transplant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2020P000374

Identifier Type: -

Identifier Source: org_study_id