Phase 4
N=30
Multi-center Study to Transplant Hepatitis-C Infected Kidneys
Renal Failure Chronic · Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT03781726 ↗Enrolled (actual)
30
Serious AEs
66.7%
Results posted
May 2021
Primary outcome: Primary: Number of Participants With Undetectable HCV — 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- glecaprevir/pibrentasvir treatment (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Raymond Chung
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Undetectable HCV |
30 | — |
| SECONDARY Percentage of Subjects With On-treatment Virologic Failure |
12 | — |
| SECONDARY Percentage of Subjects With Post-treatment Virologic Relapse |
— | — |
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.
Eligibility Criteria
Recipient Inclusion Criteria:
- Estimated glomerular filtration rate(eGFR) 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
Data sourced from ClinicalTrials.gov (NCT03781726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.