Phase 3
N=36
Utilization of Hepatitis C Positive Kidneys in Negative Recipients
Kidney Transplant · Hepatitis C · HCV
Bottom Line
View on ClinicalTrials.gov: NCT03801707 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment — 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] (Drug); Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment |
28 | — |
| PRIMARY Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies |
2; 0; 0; 28 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant |
54; 46 | — |
| SECONDARY Patient's Survival at 6 and 12 Months |
30; 30 | — |
| SECONDARY Graft Survival at 6 and 12 Months |
30; 30 | — |
Summary
To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection
Eligibility Criteria
Recipient Inclusion/Exclusion Criteria:
Inclusion Criteria
- Adult age >18 years able to provide consent
- Lack of available living donor
- Calculated pre-transplant reactive panel (cPRA) of 20% and 5 years
- Listing for multi-organ transplantation
- Active or recent history (<6 months) of alcohol abuse or substance abuse
- Clinically significant liver disease as determined by principal investigator
- History of hepatocarcinoma
- Pregnancy or lactation
- Refusal to accept blood transfusion
- HIV infection
- HCV pcr or antibody positive
- HBV infection
Donor Inclusion Criteria:
- Positive HCV PCR at time of donation
- Kidney donor profile index (KDPI)<85%
Data sourced from ClinicalTrials.gov (NCT03801707). 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.