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NCT04063865 · ClinicalTrials.gov registry record · Phase 3
Everolimus Monotherapy as Immunosuppression After Liver Transplant
A Phase 3 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 14
- Enrollment target
NCT04063865: Clinical Trial Phase 3 study, sponsored by Indiana University.
NCT04063865 is a Phase 3 study that was terminated before completion, run by Indiana University. The registered enrollment target is 14 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04063865, a Phase 3 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 14 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 have near normal kidney function prior to liver transplantation. Other investigators have already shown a benefit in terms of renal function with introduction of Everolimus with reduced-exposure tacrolimus at 1 month after liver transplantation, this benefit has been shown was maintained to 3 years in patients who continued Everolimus therapy with comparable efficacy and no late safety concerns. Investigators in this trial are proposing to advance this approach further by completely eliminating Tacrolimus from patients' immunosuppression protocol. The rationale for this approach is based on a unique induction immunosuppression protocol. 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. By completely eliminating Tacrolimus, investigators believe that there may be further benefit in terms of renal function. Additionally, Everolimus is known to induce tolerance in transplant recipients. Tolerant patients do not require immunosuppression to accept transplant organs. The long-term efficacy and safety of Everolimus monotherapy as the maintenance immunosuppression in patients receiving rATG induction is unknown. Primary Aim: Assess the effect of Everolimus monotherapy versus Tacrolimus monotherapy on long term renal function measured by Glomerular Filtration Rate (GFR).
Primary Outcome
Glomerular Filtration Rate
Interventions
- DRUG Everolimus
- DRUG Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-05-09 |
| Est. Completion | 2020-07-02 |
| Phase | Phase 3 |
Why NCT04063865 stopped before completion
NCT04063865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT04063865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04063865 about?
NCT04063865 is a clinical study titled "Everolimus Monotherapy as Immunosuppression After Liver Transplant". 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 r...
What is the current status of trial NCT04063865?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 14 participants. The study started on 2019-05-09. Estimated completion is 2020-07-02.
What interventions are being tested in trial NCT04063865?
The interventions under investigation include: Everolimus (DRUG), Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT04063865?
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 NCT04063865's enrollment target sits among peer trials
14 1983rd of 2000 higher than 17 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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