Status:
UNKNOWN
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Stanford University
United States Department of Defense
Conditions:
Pediatric Heart Transplantation
Immunosuppression
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE3
Brief 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 everolim...
Detailed Description
Median survival after pediatric heart transplantation (HT) is 15 years in the current era. This means that a substantial fraction of patients transplanted during childhood fail to survive to adulthood...
Eligibility Criteria
Inclusion
- Orthotopic heart transplantation
- Age \< 21 years at time of transplant
- 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).
Exclusion
- Multi-organ transplant (e.g. heart-lung or heart-liver).
- Known hypersensitivity to everolimus, sirolimus, tacrolimus or mycophenolate mofetil (MMF), or to components of the drug products.
- Patients on maintenance corticosteroid therapy exceeding a dose equivalent of prednisone 0.1 mg/kg/day at randomization.
- High-risk for rejection defined as active rejection, recurrent (≥ 2 episodes of grade 2R rejection) cellular rejection, recurrent rejection (≥ 2 episodes of any grade) with hemodynamic compromise, steroid-resistant rejection or unresolved antibody-mediated rejection during the first 6 months post-heart transplant
- Graft dysfunction (LVEF \<40% or wedge pressure \>22 mmHg or cardiac index \<2.2 L/min/m2)
- Stage 4 or 5 CKD (eGFR \<30 ml/min/1.73 m2)
- Moderate or severe proteinuria
- Active infection requiring hospitalization or treatment dose medical therapy.
- Patients with ongoing wound healing problems, clinically significant wound infection requiring continued therapy or other severe surgical complication in the opinion of the Site Principal Investigator.
- Fasting Serum Cholesterol ≥300 mg/dL OR greater than or equal to 7.75 mmol/L, AND fasting triglycerides ≥2.5x the upper limit of normal (ULN). Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication, and reduction of serum cholesterol and triglyceride levels to below exclusion ranges is confirmed.
- Uncontrolled diabetes mellitus.
- Diagnosis of post-transplant lymphoproliferative disorder (PTLD) during the first 6 months post-heart transplant.
- History of non-adherence to medical regimens.
- Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) and cannot discontinue the treatment
- Patients who are pregnant or breast-feeding or intend to get pregnant during the study period.
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT03386539
Start Date
January 29 2018
End Date
January 1 2024
Last Update
October 17 2023
Active Locations (25)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Loma Linda University
Loma Linda, California, United States, 92354
4
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027