NCT04063865

Everolimus Monotherapy as Immunosuppression After Liver Transplant

Terminated Phase 3 Results posted Last updated 23 May 2023

What this trial tests

Phase 3 trial testing Tacrolimus in Kidney Failure in 14 participants. Terminated before completion.

Timeline

9 May 2019

Primary endpoint
2 July 2020

2 July 2020

Quick facts

Lead sponsor	Indiana University
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	14
Start date	9 May 2019
Primary completion	2 July 2020
Estimated completion	2 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Tacrolimus (TACROLIMUS) — full drug profile →
• Everolimus (everolimus) — full drug profile →

Conditions studied

• Kidney Failure — all drugs for Kidney Failure →

Sponsor

Indiana University

Who can join

18 and older, any sex, with Kidney Failure. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year, 2 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Arm

Serious: 2/6 (33%)

Deaths: 0/6

Study Arm

Serious: 1/8 (13%)

Deaths: 0/8

Serious adverse events (3 terms)

Reaction	System	Control Arm	Study Arm
Lung Infection	Respiratory, thoracic and mediastinal disorders	—	—
Liver Infection	Hepatobiliary disorders	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Lung Infection, Liver Infection, Pleural Effusion.

Data from ClinicalTrials.gov NCT04063865 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.