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mTOR Inhibitor

Interventional Group 1 for Liver Transplant (ELIMINATE Trial)

Phase 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from visit 1 to visit 11 (20 months post-liver transplant)

Awards & highlights

ELIMINATE Trial 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.Check my eligibility

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.See study design

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.

ELIMINATE Trial 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.

ELIMINATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from visit 1 to visit 11 (20 months post-liver transplant)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from visit 1 to visit 11 (20 months post-liver transplant)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from visit 1 to visit 11 (20 months post-liver transplant) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change in estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation. Between Cohorts INT-1 and INT-2

Proportion of subjects with treated Biopsy Proven Acute Rejection (tBPAR) per local pathology. Between cohorts INT-1 and INT-2

Secondary outcome measures

Changes in liver graft function: Alanine Aminotransaminase (ALT)

Changes in liver graft function: Alkaline Phosphatase

Changes in liver graft function: Aspartate Aminotransferase (AST)

+19 more

ELIMINATE 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,484,897 Total Patients Enrolled

Josh Levitsky, MD, MSPrincipal InvestigatorNorthwestern University Feinberg School of Medicine: Transplantation

2 Previous Clinical Trials

230 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to participate in this research study?

"Information from clinicaltrials.gov shows that while this specific trial is no longer recruiting participants since 2/20/2024, there are 52 alternative trials currently open for patient enrollment."

Answered by AI

At how many distinct sites is the management of this study taking place?

"Patients can enroll in this trial at Mayo Clinic Hospital Arizona (Site #: 71144) situated in Phoenix, Arizona; University of California, San Francisco (Site #: 71108) located in San Francisco, California; and Northwestern University (Site #: 71110) based in Chicago, Illinois. Additionally, the study is available at eight more undisclosed locations."

Answered by AI

Has the first interventional group been officially endorsed by the FDA?

"On a scale of 1 to 3, our evaluation at Power suggests that the safety rating for Interventional Group 1 stands at 2. This determination is based on the fact that this trial belongs to Phase 2, indicating existing data supporting safety with no evidence yet backing efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Expanding Liver Transplant Immunosuppression Minimization Via Everolimus

2024. "Expanding Liver Transplant Immunosuppression Minimization Via Everolimus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06280950.

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