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Immunosuppressant

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

Phase 3

Waitlist Available

Led By Lynn A Sleeper, ScD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization

Awards & highlights

Pivotal Trial

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial will compare two different treatments for kids who have had a heart transplant, to see which one is better at reducing the risk of problems like coronary artery disease, kidney disease, and rejection of the transplant.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include increased risk of infections due to immune system suppression; potential damage to kidneys; development of lymphoproliferative disorders; blood lipid abnormalities; wound healing complications; and possible adverse reactions specific to each drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

EFFICACY: MATE-3 Score

SAFETY: MATE-6 Score

Secondary study objectives

Efficacy: Change in CKD stage

Efficacy: Change in kidney function

Efficacy: Composite score consisting of MATE CAV, MATE BP-ACR, change in CKD stage, and any CMV infection.

+23 more

Side effects data

From 2017 Phase 4 trial • 60 Patients • NCT02096107

20%

Hospitalization

20%

Immunosuppression held or modified

10%

Infections

100%

80%

60%

40%

20%

Study treatment Arm

Standard of Care

Low Intensity Tacrolimus

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Everolimus

FDA approved

Tacrolimus

FDA approved

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