Tacrolimus + Everolimus vs. Tacrolimus + MMF for Heart Transplant Care
(TEAMMATE Trial)

Recruiting in Palo Alto (17 mi)

+24 other locations

Overseen byLynn A Sleeper, ScD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Boston Children's Hospital

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years. Half of the participants will receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and mycophenolate mofetil. The trial will determine which treatment is better at reducing the cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy proven-acute cellular rejection without an increase in graft loss due to all causes (e.g. infection, PTLD, antibody mediated rejection).

Eligibility Criteria

This trial is for pediatric heart transplant patients under 21 years old, at least 6 months post-transplant. They must be on stable immunosuppression without contraindications to the study drugs and not pregnant or breastfeeding. Exclusions include multi-organ transplants, high rejection risk, severe kidney disease, uncontrolled diabetes, PTLD history within six months of transplant, and certain medication interactions.

Inclusion Criteria

Stable immunosuppression at the time of randomization with no contraindication to everolimus, tacrolimus, or mycophenolate mofetil

Planned follow-up at a study site for the 30 month duration of the study

Subject or legal adult representative capable of providing informed consent (in general, assent will be sought for children aged 12 years or older)

+2 more

Exclusion Criteria

Patients who are pregnant or breast-feeding or intend to get pregnant during the study period

You have had multiple organ transplants, like getting a new heart and a new liver at the same time.

You are allergic to everolimus, sirolimus, tacrolimus, or mycophenolate mofetil, or any parts of the medication.

+12 more

Participant Groups

The TEAMMATE Trial compares two drug combinations in children who've had a heart transplant: everolimus with low-dose tacrolimus versus tacrolimus with mycophenolate mofetil. It aims to see which regimen better reduces risks of artery problems, kidney disease and organ rejection over a period of 2.5 years.

2Treatment groups

Experimental Treatment

Active Control

Group I: Everolimus/Low-Dose TacrolimusExperimental Treatment2 Interventions

Everolimus approximately 0.6 mg/m2/dose taken by mouth every 12 hours for 30 months. Everolimus dose will be adjusted to achieve a trough concentration of 3-8 ng/ml. Tacrolimus 0.0125 mg/kg/dose by mouth every 12 hours for 30 months. (Tacrolimus dose will be adjusted to achieve a trough concentration of 3-5 ng/ml until subjects are 1 year post-heart transplant. After 1 year post-heart transplant the tacrolimus dose will be adjusted to achieve a trough concentration of 2.5-4.5 ng/mL.)

Group II: Tacrolimus/Mycophenolate MofetilActive Control2 Interventions

Tacrolimus 0.05 mg/kg/dose by mouth every 12 hours for 30 months. (Tacrolimus dose will be adjusted to achieve a trough concentration of 7-10 ng/ml until subjects are 1 year post-heart transplant. After 1 year post-heart transplant the tacrolimus dose will be adjusted to achieve a trough concentration of 5-8 ng/mL.) Mycophenolate mofetil 600 mg/m2/dose by mouth every 12 hours for 30 months.

Everolimus is already approved in United States, European Union, United States for the following indications:

🇺🇸 Approved in United States as Afinitor for: