Phase 4
Completed N=10
Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors
Source: ClinicalTrials.gov NCT04575896 ↗Enrolled (actual)
10
Serious AEs
40.0%
Results posted
Jan 2024
Primary outcomePrimary: Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA — 10 Participants
◆ Published Evidence
Established
49citations · ~10 / year
Four-Week Direct-Acting Antiviral Prophylaxis for Kidney Transplantation From Hepatitis C-Viremic Donors to Hepatitis C-Negative Recipients: An Open-Label Nonrandomized Study.
Summary
In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 2 weeks post-renal transplant.
Linked Publications
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Four-Week Direct-Acting Antiviral Prophylaxis for Kidney Transplantation From Hepatitis C-Viremic Donors to Hepatitis C-Negative Recipients: An Open-Label Nonrandomized Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA |
10 | — |
Eligibility Criteria
Recipient Inclusion Criteria:
- Participants ≥ 18 years old
- On the deceased donor kidney waitlist at Johns Hopkins Hospital
- Awaiting a first or second kidney transplant
- No available living kidney donors
- On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate <15 ml/min for ≥ past 90 days
- HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors for contracting HCV other than being on hemodialysis
- Calculated panel reactive anti-human leukocyte antigens (anti-HLA) antibody (flow cPRA) below 80%
Recipient Exclusion Criteria:
- Plan to receive a multi-organ transplant
- Plan to receive a dual kidney transplant (including en bloc)
- History of prior solid organ transplant other than first kidney transplant
- Participating in another study that involves an intervention or investigational product
- Plan to receive a blood type incompatible kidney
- History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B (HBV) infection, defined as being on active antiviral treatment for HBV, detectable hepatitis B surface Ag or detectable hepatitis B DNA
- Unable to safely substitute or discontinue a medication that is contraindicated with the study medication
- Psychiatric or physical illness that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study
Data sourced from ClinicalTrials.gov (NCT04575896) and the linked publication. 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. Informational only — not medical advice.