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NCT04075916 · ClinicalTrials.gov registry record · Phase 2
A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 201
- Enrollment target
NCT04075916: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT04075916 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 201 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04075916, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 201 participants
- Enrollment target
Study Summary
The Transplanting Hepatitis C Kidneys into Negative KidnEy Recipients \[THINKER-NEXT\] study will include adult kidney transplant candidates without hepatitis C virus (HCV) infection on the transplant waiting list who will consent to kidney transplantation from a deceased donor infected with HCV, followed by treatment with a direct acting antiviral. The one-year allograft function and one-year risk of CMV infection will be compared between THINKER-NEXT kidney transplant recipients and matched recipients who received hepatitis C uninfected kidney transplants (these patients are called Transplant Cohort). The survival rate of patients opting-in for offers of kidneys from HCV-viremic donors will be compared to the survival rate of matched comparators from the kidney transplant waitlist who did not consent to receive offers of a HCV-viremic kidney. Lastly, renal pathologic findings will be compared among HCV-viremic donors and HCV-negative comparator donors.
Interventions
- DRUG Epclusa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2021-06-22 |
| Est. Completion | 2026-02-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04075916
The ClinicalTrials.gov registry entry for NCT04075916 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Epclusa is the first listed.
NCT04075916 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04075916 about?
NCT04075916 is a clinical study titled "A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients". The Transplanting Hepatitis C Kidneys into Negative KidnEy Recipients \[THINKER-NEXT\] study will include adult kidney transplant candidates without hepatitis C virus (HCV) infection on the transplant waiting list who will consent to kidney transplantation from a deceased donor infected with HCV, fo...
What is the current status of trial NCT04075916?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 201 participants. The study started on 2021-06-22. Estimated completion is 2026-02-25.
What interventions are being tested in trial NCT04075916?
The interventions under investigation include: Epclusa (DRUG).
Who is sponsoring clinical trial NCT04075916?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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