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Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score

NCT03386539 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2023-10-17

No results posted yet for this study

Summary

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).

Conditions

  • Pediatric Heart Transplantation
  • Immunosuppression
  • Chronic Kidney Diseases
  • Cardiac Allograft Vasculopathy
  • Heart Transplant Failure and Rejection
  • Post-transplant Lymphoproliferative Disorder
  • Heart Transplant Infection

Interventions

DRUG

Everolimus

Everolimus tablet

DRUG

Tacrolimus

Tacrolimus capsule or liquid suspension

DRUG

Mycophenolate Mofetil

Mycophenolate Mofetil capsule or liquid suspension

Sponsors & Collaborators

Principal Investigators

  • Christopher S Almond, MD, MPH · Stanford University

  • Kevin P Daly, MD · Boston Children's Hospital

  • Lynn A Sleeper, ScD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-29
Primary Completion
2023-04-17
Completion
2024-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386539 on ClinicalTrials.gov