Back to resultsHCV + to HCV - Kidney Transplant
Primary Purpose
Kidney Failure, Hepatitis C
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Direct Acting Antivirals
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Failure focused on measuring Kidney Transplant, Kidney Failure, HCV, Hepatitis C
Eligibility 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 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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with Direct Acting Antiviral for HCV
Arm Description
8 weeks of treatment with HCV Direct Acting Antiviral tablet
Outcomes
Primary Outcome Measures
Undetectable HCV RNA
Negative HCV RNA 12 weeks after last dose of 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
Secondary Outcome Measures
Full Information
NCT ID
NCT04320290
First Posted
March 23, 2020
Last Updated
August 29, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04320290
Brief Title
HCV + to HCV - Kidney Transplant
Official Title
Hepatitis C Viral Kidneys Used for Non-Viremic Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
New Related Protocol to be submitted
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
June 16, 2020 (Actual)
Study Completion Date
June 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Hepatitis C
Keywords
Kidney Transplant, Kidney Failure, HCV, Hepatitis C
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Direct Acting Antiviral for HCV
Arm Type
Experimental
Arm Description
8 weeks of treatment with HCV Direct Acting Antiviral tablet
Intervention Type
Drug
Intervention Name(s)
Direct Acting Antivirals
Other Intervention Name(s)
Direct Acting Antiviral HCV Treatment
Intervention Description
8 weeks of DAA treatment
Primary Outcome Measure Information:
Title
Undetectable HCV RNA
Description
Negative HCV RNA 12 weeks after last dose of treatment
Time Frame
12 weeks post-treatment
Title
Rate of Serious and non-serious adverse events
Description
Determine safety of HCV+ to HCV- kidney transplantation by determining rate of adverse events related to HCV viremia or DAA treatment
Time Frame
1 year post-transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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)
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anticipate to share coded data with collaborators
IPD Sharing Time Frame
Ancicipate data would be available to share by 6 months are the final patient visit.
IPD Sharing 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.
Learn more about this trial
HCV + to HCV - Kidney Transplant
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