Status:
COMPLETED
Multi-center Study to Transplant Hepatitis-C Infected Kidneys
Lead Sponsor:
Raymond Chung
Collaborating Sponsors:
AbbVie
University of Pennsylvania
Conditions:
Renal Failure Chronic
Hepatitis C
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
Brief Summary
Open label multi center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.
Detailed Description
The study objective is to determine if the administration of the direct acting antiviral glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective at preventing the ...
Eligibility Criteria
Inclusion
- Recipient
- Estimated glomerular filtration rate(eGFR) \< 15 ml/min/1.73 m2
- Listed for an isolated kidney transplantation
- Able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent
- No available medically acceptable, compatible living kidney donor
- Subject must agree to use an effective method of birth control per protocol specifications
- Recipient
Exclusion
- History of severe, life-threatening or other significant sensitivity to immunosuppressants utilized in kidney transplant
- Female who is pregnant, breastfeeding, or is planning to become pregnant during the course of the study
- History of HIV
- HCV RNA positive
- HBV surface Ag-positive or detectable HBV DNA
- Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or investigator team
- Presence of clinically significant liver disease
- Transplant candidate requiring antibody desensitization protocol for transplantation
- Most recent calculated panel reactive antibody (cPRA) \>80%.
- Prior recipient of a non-renal solid organ transplant
- Donor Organ Inclusion Criteria
- Deceased donor organ with kidney donor profile index (KDPI) ≤0.85
- HCV RNA-positive
- Donor Organ Exclusion Criteria
- Known prior HCV treatment with direct acting antiviral medication
- HIV RNA-positive
- HBV Surface antigen-positive or HBV DNA-positive
Key Trial Info
Start Date :
April 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03781726
Start Date
April 10 2019
End Date
December 31 2021
Last Update
January 26 2022
Active Locations (7)
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1
Northwestern Medicine
Chicago, Illinois, United States, 60611
2
John Hopkins
Baltimore, Maryland, United States, 21287
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
University of Michigan
Ann Arbor, Michigan, United States, 48109