HCV + to HCV - Kidney Transplant

NCT04320290 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2020P000374
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Failure; Hepatitis C

Keywords

Kidney Transplant; Kidney Failure; HCV; Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Undetectable HCV RNA

  Negative HCV RNA 12 weeks after last dose of treatment

  12 weeks post-treatment

• 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

Study Arms (1)

Treatment with Direct Acting Antiviral for HCV

EXPERIMENTAL

8 weeks of treatment with HCV Direct Acting Antiviral tablet

Drug: Direct Acting Antivirals

Interventions

Direct Acting Antivirals DRUG

8 weeks of DAA treatment

Also known as: Direct Acting Antiviral HCV Treatment

Treatment with Direct Acting Antiviral for HCV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Renal Insufficiency; Hepatitis C

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Director, Kidney Transplant

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 24, 2020
• Study Start: May 21, 2020
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Ancicipate data would be available to share by 6 months are the final patient visit.
• Access Criteria: Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.