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mTOR Inhibitor

Everolimus for Liver Transplant (ELIMINATE Trial)

Phase 2

Recruiting

Led By Josh Levitsky, MD, MS

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult recipient of first liver transplant alone (de novo)

Treatment with tacrolimus therapy, with or without mycophenolic acid derivatives and/or corticosteroids

Must not have

History of prior organ transplantation (liver or other type)

History of >= 2 biopsy-proven acute cellular rejection episodes of any severity, >=1 moderate to severe rejection episode (histologically defined or requiring lymphodepletion therapy), or >= 1 antibody- mediated rejection episode

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if it's safe to stop using a certain anti-rejection drug called tacrolimus after a liver transplant. The study will involve 270 participants who will be split into two

Who is the study for?

This trial is for liver transplant recipients looking to minimize anti-rejection medication. Participants should be 2-3 months post-transplant and willing to potentially switch from tacrolimus to everolimus therapy. The study excludes those not stable on current medications or with conditions that may interfere with the trial.

What is being tested?

The study tests if taking patients off tacrolimus (an anti-rejection drug) and using everolimus instead can better preserve kidney function after a liver transplant. It's a randomized trial where some will reduce their current meds, while others will switch to everolimus.

What are the potential side effects?

Possible side effects include issues related to immune suppression such as increased infection risk, potential kidney problems due to medication changes, and general intolerance of the new drug regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have received my first liver transplant.

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I am currently on tacrolimus, possibly with mycophenolic acid or steroids.

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I am a woman who can have children and my pregnancy test is negative.

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My kidney function, measured by filtration rate, is adequate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ transplant in the past.

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I have had 2 or more episodes of organ rejection after a transplant.

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I am currently taking medication that includes everolimus or sirolimus.

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I cannot take everolimus due to specific health issues.

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I have an autoimmune disease that needs immunosuppressive therapy not related to this study.

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I have not received any live vaccines in the last 2 months.

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I am currently fighting a serious infection that needs strong medication.

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I have had a blood clot in my liver's artery or vein.

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I am not on long-term steroids, immune therapies, or other immune-suppressing drugs not allowed by the study.

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I have hepatitis B or C with detectable virus levels.

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I have a history of autoimmune liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Interventional Group 2Experimental Treatment2 Interventions

Participants in this group will continue to take reduced Tacrolimus and Everolimus IS regimen.

Group II: Interventional Group 1Experimental Treatment2 Interventions

Participants in this group will slowly reduce their dose of tacrolimus and continue everolimus as their only immunosuppression medication.

Group III: Observational GroupActive Control1 Intervention

Participants in this group could not tolerate the addition of everolimus. These participants will not be randomized. * Participants in this group will stop taking everolimus. * Participants in this group will resume taking their tacrolimus +/- mycophenolate compound and prednisone immunosuppression regimen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Everolimus

2010

Completed Phase 4

~1510

0 / 15Eligibility criteria met