| Trial ID: | L1733 |
| Source ID: | NCT03386539
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| Associated Drug: |
Everolimus
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| Title: |
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
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| Acronym: |
TEAMMATE
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| Status: |
ACTIVE_NOT_RECRUITING
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Pediatric Heart Transplantation|Immunosuppression|Chronic Kidney Diseases|Cardiac Allograft Vasculopathy|Heart Transplant Failure and Rejection|Post-transplant Lymphoproliferative Disorder|Heart Transplant Infection
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| Interventions: |
DRUG: Everolimus|DRUG: Tacrolimus|DRUG: Mycophenolate Mofetil
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| Outcome Measures: |
Primary: EFFICACY: MATE-3 Score, MATE-3 is a validated score ranging from 0 to 12. The score represents the cumulative burden of three major adverse transplant events: Coronary Artery Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR), 30 months post-randomization|SAFETY: MATE-6 Score, MATE-6 is a validated score ranging from 0 to 24. The score represents the cumulative burden of all six major adverse transplant events: Coronary Artery Vasculopathy (CAV), Chronic Kidney Disease (CKD), Biopsy-proven Acute Cellular Rejection (ACR), pathologic diagnosis of Antibody-Mediated Rejection (AMR), Infection, and Post-Transplant Lymphoproliferative Disorder (PTLD), 30 months post-randomization | Secondary: Efficacy: Overall patient survival, Freedom from death from any cause, Up to 30 months post-randomization|Efficacy: Overall allograft survival, Freedom from death and re-transplantation, Up to 30 months post-randomization|Efficacy: Change in kidney function, Change in estimated glomerular filtration rate (eGFR) using the modified Schwartz equation, 0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization|Efficacy: Freedom from CKD event, Chronic Kidney Disease (CKD), Follow-up through 30 months post-randomization|Efficacy: Freedom from CAV event, Coronary Artery Vasculopathy (CAV), Follow-up through 30 months post-randomization|Efficacy: Freedom from BP-ACR event, Biopsy-proven Acute Cellular Rejection (ACR), Follow-up through 30 months post-randomization|Efficacy: Freedom from composite failure, The qualifying event is the earliest occurrence of death, graft loss, 2R/3R ACR rejection or rejection with HD, Follow-up through 30 months post-randomization|Efficacy: Lansky and Karnofsky scores, Validated functional performance score, assigned by clinician assessment: Lansky score if \< 16 years at randomization; Karnofsky if \>=16 years at randomization, 18 and 30 months post-randomization|Efficacy: EuroQOL EQ-5D Y (Youth Version), Completed by study participant except for: EQ-5D-Y Proxy version will be used for children ≥ 4 years but less than 8 years at randomization or children ≥ 8 years who are unable to complete the EQ-5D-Y., 18 and 30 months post-randomization|Safety: Freedom from AMR, Pathologic diagnosis of Antibody-Mediated Rejection (AMR), Follow-up through 30 months post-randomization|Safety: Freedom from infection, Infection, Follow-up through 30 months post-randomization|Safety: Freedom from PTLD, Post-Transplant Lymphoproliferative Disorder (PTLD), Follow-up through 30 months post-randomization|Safety: Frequency and incidence of adverse events including, but not limited to, hyperlipidemia, anemia, thrombocytopenia, interstitial lung disease, aphthous stomatitis, proteinuria, and rash, These AEs will be reported as individual endpoints as well as a composite., Follow up through 30 months post-randomization|Safety: Freedom from Major Transplant Events (Composite), The qualifying event is the earliest occurrence of CKD, CAV, ACR, AMR, infection, and PTLD, Follow-up through 30 months post-randomization|Safety: Freedom from Level 2 severity CKD Event, Chronic Kidney Disease, Follow-up through 30 months post-randomization|Safety: Freedom from Level 2 severity CAV Event, Coronary artery vasculopathy, Follow-up through 30 months post-randomization|Safety: Freedom from Level 2 severity ACR Event, Biopsy-proven Acute Cellular Rejection, Follow-up through 30 months post-randomization|Safety: Freedom from Level 2 severity AMR Event, Pathologic diagnosis of Antibody-Mediated Rejection, Follow-up through 30 months post-randomization|Safety: Freedom from Level 2 severity Infection Event, Infection, Follow-up through 30 months post-randomization|Safety: Freedom from Level 2 severity PTLD Event, Post-transplant Lymphoproliferative Disorder, Follow-up through 30 months post-randomization|Efficacy: Freedom from composite of CAV, CKD, BP-ACR, or any CMV infection, The event is the earliest occurrence of CAV, MATE CKD, BP-ACR, or any CMV infection., Follow-up through 30 months post-randomization|Efficacy: Change in CKD stage, Change in chronic kidney disease stage where improvements in CKD stage can take on a negative value., Baseline visit through 30 months post-randomization|Efficacy: MATE-3 score where CKD score is calculated by change from baseline visit, MATE-3 score where the CKD score is the change in MATE-CKD score from baseline visit through 30 months post-randomization., Baseline visit through 30 months post-randomization|Efficacy: MATE-3 score where CKD score is replaced by change in CKD stage, MATE-3 score where the CKD score is replaced by change in CKD stage from baseline visit through 30 months post-randomization., Baseline visit through 30 months post-randomization|Efficacy: Composite score consisting of MATE CAV, MATE BP-ACR, change in MATE CKD score, and any CMV infection., Efficacy: Composite score consisting of MATE CAV, MATE BP-ACR, change in MATE CKD score from baseline visit, and any CMV infection., Baseline visit through 30 months post-randomization|Efficacy: Composite score consisting of MATE CAV, MATE BP-ACR, change in CKD stage, and any CMV infection., Efficacy: Composite score consisting of MATE CAV, MATE BP-ACR, change in CKD stage from baseline visit, and any CMV infection., Baseline visit through 30 months post-randomization
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| Sponsor/Collaborators: |
Sponsor: Boston Children's Hospital | Collaborators: Stanford University|United States Department of Defense
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| Gender: |
ALL
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| Age: |
CHILD, ADULT
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| Phases: |
PHASE3
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| Enrollment: |
211
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2018-01-29
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| Completion Date: |
2024-01
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| Results First Posted: |
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| Last Update Posted: |
2023-10-17
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| Locations: |
Children's of Alabama, Birmingham, Alabama, 35233, United States|Phoenix Children's Hospital, Phoenix, Arizona, 85016, United States|Loma Linda University, Loma Linda, California, 92354, United States|Children's Hospital Los Angeles, Los Angeles, California, 90027, United States|UCLA Mattel Children's Hospital, Los Angeles, California, 90095, United States|Stanford University, Palo Alto, California, 94304, United States|Children's Hospital Colorado, Aurora, Colorado, 80045, United States|Children's National Medical Center, Washington, District of Columbia, 20010, United States|University of Florida Congenital Heart Center, Gainesville, Florida, 32610-0297, United States|Joe DiMaggio Children's Hospital, Hollywood, Florida, 33021, United States|Children's Healthcare of Atlanta Emory, Atlanta, Georgia, 30322, United States|Lurie Children's Hospital, Chicago, Illinois, 60611, United States|Boston Children's Hospital, Boston, Massachusetts, 02115, United States|University of Michigan Medical Center, Ann Arbor, Michigan, 48109, United States|Washington University in St. Louis School of Medicine, Saint Louis, Missouri, 63110, United States|Children's Hospital at Montefiore, Bronx, New York, 10803, United States|Children's Hospital of New York, New York, New York, 10032, United States|Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States|The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|Children's Hospital of Pittsburgh of University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, 15224, United States|Children's Health Dallas University of Texas Southwestern, Dallas, Texas, 75235, United States|Texas Children's Hospital, Houston, Texas, 77027, United States|Primary Children's Hospital, Salt Lake City, Utah, 84132, United States|Seattle Children's Hospital, Seattle, Washington, 98105, United States|Children's Hospital of Wisconsin, Milwaukee, Wisconsin, 53226, United States
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| URL: |
https://clinicaltrials.gov/show/NCT03386539
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