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NCT04258423 · ClinicalTrials.gov registry record · Phase 3
Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function
A Phase 3 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 4
- Enrollment target
NCT04258423: Clinical Trial Phase 3 study, sponsored by Indiana University.
NCT04258423 is a Phase 3 study that was terminated before completion, run by Indiana University. The registered enrollment target is 4 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04258423, a Phase 3 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4 participants
- Enrollment target
Study Summary
Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the nephrotoxicity side effects of Tacrolimus. Replacement of Tacrolimus by Everolimus may have a reduced incidence of renal dysfunction in liver transplant patients who already have chronic kidney disease or peri-operative acute kidney injury. Liver transplant patients receive potent induction immunosuppression in the form of rabbit anti thymocyte globulin. Investigators believe that in conjunction with this induction regimen, patients can be maintained on Everolimus monotherapy without the risk of rejection. Additionally, Everolimus is known to induce tolerance in transplant recipients. Tolerant patients do not require immunosuppression to accept transplant organs. Tacrolimus is a widely used in liver transplant recipients for immunosuppression, however it is associated with nephrotoxicity. Everolimus, on the other hand lacks nephrotoxicity. Whether replacement of tacrolimus by Everolimus preserves kidney function in patients with pre-existing chronic kidney disease or acute kidney injury is not well established. Also, the efficacy and safety of reduced-dose Everolimus with or without Mycophenolate Mofetil in prevention of rejection is unknown. Primary Aim Assess the effect of Everolimus with or without Mycophenolate Mofetil versus Tacrolimus plus Mycophenolate Mofetil therapy on renal function measured by Glomerular Filtration Rate (GFR). Secondary Aims Compare the efficacy of Everolimus plus Mycophenolate Mofetil versus Tacrolimus plus Mycophenolate Mofetil therapy as measured by the following: * Biopsy-confirmed acute rejection * Hyperlipidemia * Proteinuria * % regulatory T-cells in circulation * NODAT \[New Onset Diabetes mellitus After Transplant\], hypertension and malignancy * Tolerance measured by gene profiling at year 1, 2 and 3
Primary Outcome
Glomerular Filtration Rate
Interventions
- DRUG Everolimus
- DRUG Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2020-06-27 |
| Phase | Phase 3 |
Why NCT04258423 stopped before completion
NCT04258423 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT04258423 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04258423 about?
NCT04258423 is a clinical study titled "Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function". Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the nephrotoxicity side effects of Tacrolimus. Replacement of Tacrolimus by Everolimus may have a reduced incidence of re...
What is the current status of trial NCT04258423?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2019-12-19. Estimated completion is 2020-06-27.
What interventions are being tested in trial NCT04258423?
The interventions under investigation include: Everolimus (DRUG), Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT04258423?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04258423's enrollment target sits among peer trials
4 1998th of 2000 higher than 2 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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