Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% higher). 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.
Primary Outcome
The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR-12; negative HCV RNA 12 weeks after completing Epclusa therapy)/(number of subjects treated with Epclusa post-kidney transplantation)
Interventions
- DRUG Epclusa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2021-06-22 |
| Est. Completion | 2026-02-25 |
| Phase | Phase 2 |
What the finished NCT04075916 record still lists
NCT04075916 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% higher).
The record links to 0 conditions, and to 1 intervention - of which Epclusa is the first listed.
NCT04075916 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04075916's enrollment target sits among peer trials
201 302nd of 2000 higher than 1,697 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04422652 · 201 participants · Phase 2
Combination of Novel Therapies for CKD Comorbid Depression
- NCT05327114 · 201 participants · Phase 2
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- NCT06099769 · 201 participants · Phase 2
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
- NCT06274528 · 201 participants · Phase 2
DORA and LP in Alzheimer's Disease Biomarkers
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI