Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
Фаза 3
Завершено
NCT03386539
| Заболевание | Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy |
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| Фаза | Фаза 3 |
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| Спонсор | Boston Children's Hospital |
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| Статус | Завершено |
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| Участники | 211 участн. |
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| Вмешательство | Everolimus, Tacrolimus, Mycophenolate Mofetil |
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| Дата начала | 29.01.2018 |
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| Дата завершения | 17.04.2023 |
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| Публикация результатов | 31.07.2026 |
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Кратко
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).
EFFICACY: MATE-3 Score
30 months post-randomization · Scores on a scale
| Everolimus/Low-Dose Tacrolimus | 0.9 ± 2.2 Scores on a scale |
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| Tacrolimus/Mycophenolate Mofetil | 1.3 ± 2.5 Scores on a scale |
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| p-value | 0.16 |
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| Mean Difference (Net) | -0.32 (95% CI -0.90–0.20) |
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SAFETY: MATE-6 Score
30 months post-randomization · Scores on a scale
| Everolimus/Low-Dose Tacrolimus | 2.0 ± 4.6 Scores on a scale |
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| Tacrolimus/Mycophenolate Mofetil | 2.4 ± 5.2 Scores on a scale |
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| Mean Difference (Net) | -0.4 (95% CI -1.8–0.9) |
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