Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
3期
已完成
NCT03386539
| 适应症 | Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy |
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| 分期 | 3期 |
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| 申办方 | Boston Children's Hospital |
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| 状态 | 已完成 |
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| 受试者人数 | 211 人 |
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| 干预（药物） | Everolimus, Tacrolimus, Mycophenolate Mofetil |
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| 开始日期 | 2018年1月29日 |
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| 完成日期 | 2023年4月17日 |
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| 结果公布日 | 2026年7月31日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。