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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 is a Phase 3 study that was terminated before completion, run by Indiana University. The registered enrollment target is 4 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04258423
The ClinicalTrials.gov registry entry for NCT04258423 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT04258423 reports 0 study locations.
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.
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