BENITIONSClinical Trial Intelligence

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

第3相 完了 NCT03386539

対象疾患Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy
第3相
スポンサーBoston Children's Hospital
ステータス完了
参加者数211 名
介入(薬剤)Everolimus, Tacrolimus, Mycophenolate Mofetil
開始日2018年1月29日
完了日2023年4月17日
結果公開日2026年7月31日

概要

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 Tacrolimus0.9 ± 2.2 Scores on a scale
Tacrolimus/Mycophenolate Mofetil1.3 ± 2.5 Scores on a scale
p-value0.16
Mean Difference (Net)-0.32 (95% CI -0.90–0.20)

SAFETY: MATE-6 Score

30 months post-randomization · Scores on a scale

Everolimus/Low-Dose Tacrolimus2.0 ± 4.6 Scores on a scale
Tacrolimus/Mycophenolate Mofetil2.4 ± 5.2 Scores on a scale
Mean Difference (Net)-0.4 (95% CI -1.8–0.9)

BENITIONS で見る ClinicalTrials.gov の原文を見る

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