Expanding Liver Transplant Immunosuppression Minimization Via Everolimus

Conditions

• Liver Transplant

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Everolimus — DRUG
  * The first step is the addition of everolimus to participants in this group pre-randomization. * Participants on a mycophenolate compound will stop taking it within 7 days of initiating everolimus, either by immediate discontinuation or a 7-day taper. * Participants taking prednisone will taper off prednisone by 6 months post-transplant. * The second step is tacrolimus minimization and withdrawal to everolimus monotherapy in this group after randomization.
• Tacrolimus (continued reduction) — DRUG
  * Participants randomized in this cohort will have their tacrolimus dose reduced by 50% following randomization. * They will maintain this daily dose for 4 weeks/1 month (28-30 days). Tacrolimus withdrawal will occur in intervals of 30 days or 4 weeks. * Each subsequent reduction will be based on LFT stability over the prior time interval before the next reduction
• Tacrolimus (maintain 50% reduction) — DRUG
  \- Participants randomized in this cohort maintain initial reduced dose of Tacrolimus and everolimus for study duration.
• Everolimus — DRUG
  * The first step is the addition of everolimus to participants in the interventional group pre-randomization. * Participants on a mycophenolate compound will stop taking it within 7 days of initiating everolimus, either by immediate discontinuation or a 7-day taper. * Participants taking prednisone will taper off prednisone by 6 months post-transplant. * The second step is to continue on the reduced tacrolimus and everolimus regimen.

Study Details

This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months.

Key Dates

Start date

Sep 12, 2024

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2030

Study Design

Enrollment

340 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Interventional Group 1
  Participants in this group will slowly reduce their dose of tacrolimus and continue everolimus as their only immunosuppression medication.
• Experimental: Interventional Group 2
  Participants in this group will continue to take reduced Tacrolimus and Everolimus IS regimen.
• No Intervention: Observational Group
  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.

Primary Outcome Measure

Percent change in estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation. Between Cohorts INT-1 and INT-2 [ Time Frame: From Visit 2 to Visit 9 (12 months post-liver transplant) ]

Central Contacts

• Tracia Debnam, MS
  301-761-7414
  [email protected]

Locations (8)

Find similar trials in Phoenix, AZ

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