BENITIONSClinical Trial Intelligence

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

3상 완료 NCT03386539

대상 질환Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy
임상 단계3상
스폰서Boston Children's Hospital
상태완료
참여자 수211 명
중재(약물)Everolimus, Tacrolimus, Mycophenolate Mofetil
시작일2018년 1월 29일
완료일2023년 4월 17일
결과 공개일2026년 7월 31일

요약

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)

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