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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 is a Phase 3 study that was terminated before completion, run by Indiana University. The registered enrollment target is 14 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04063865
The ClinicalTrials.gov registry entry for NCT04063865 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 14 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.
NCT04063865 reports 0 study locations.
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.
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