Phase 4
N=10
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
End Stage Renal Disease · Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT03627299 ↗Enrolled (actual)
10
Serious AEs
30.0%
Results posted
Aug 2020
Primary outcome: Primary: Viral Response at Week 12 — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 300mg glecaprevir/pibrentasivir 120mg (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Viral Response at Week 12 |
10 | — |
| PRIMARY Number of Participants With Grade 3 or Higher Treatment-related Adverse Events Related to the Use of G-P |
— | — |
| SECONDARY Viral Response at 1 Week |
8 | — |
| SECONDARY Viral Response at 2 Weeks |
10 | — |
| SECONDARY Viral Response at 4 Weeks |
10 | — |
| SECONDARY Viral Response at 8 Weeks |
10 | — |
| SECONDARY Antibody Development |
9 | — |
| SECONDARY T-cell Response at Baseline |
6; 1; 2; 1 | — |
| SECONDARY T-cell Response at 12 Weeks |
5; 3; 1; 1 | — |
| SECONDARY Kidney Function at 6 Months |
1.32 | — |
| SECONDARY Kidney Function at 12 Months |
1.33 | — |
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 4 weeks post-renal transplant.
Eligibility Criteria
Recipient Inclusion Criteria
- Participants ≥ 40 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 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 antigen antibody (cPRA) below 80%
Recipient Exclusion Criteria
- Plan to receive a multi-organ transplant
- Plan to receive a dual kidney transplant (including en bloc)
- Prior solid organ 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 (NCT03627299). 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.