Pediatric Heart TransplantationPhase 3TEAMMATENCT03386539
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
A Phase 3 study testing Everolimus, Tacrolimus and Mycophenolate Mofetil in people with Pediatric Heart Transplantation and Immunosuppression, run by Boston Children's Hospital at 25 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases
- What is being tested?
- Everolimus, Tacrolimus and Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 25 sitesUnited States
- Study dates
- 29 Jan 2018to 17 May 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Orthotopic heart transplantation
- Age < 21 years at time of transplant
- Stable immunosuppression at the time of randomization with no contraindication to everolimus, tacrolimus, or mycophenolate mofetil
- Planned follow-up at a study site for the 30 month duration of the study.
- Subject or legal adult representative capable of providing informed consent (in general, assent will be sought for children aged 12 years or older).
Who cannot join
- Multi-organ transplant (e.g. heart-lung or heart-liver).
- Known hypersensitivity to everolimus, sirolimus, tacrolimus or mycophenolate mofetil (MMF), or to components of the drug products.
- Patients on maintenance corticosteroid therapy exceeding a dose equivalent of prednisone 0.1 mg/kg/day at randomization.
- High-risk for rejection defined as active rejection, recurrent (≥ 2 episodes of grade 2R rejection) cellular rejection, recurrent rejection (≥ 2 episodes of any grade) with hemodynamic compromise, steroid-resistant rejection or unresolved antibody-mediated rejection during the first 6 months post-heart transplant
- Graft dysfunction (LVEF <40% or wedge pressure >22 mmHg or cardiac index <2.2 L/min/m2)
- Stage 4 or 5 CKD (eGFR <30 ml/min/1.73 m2)
Show all 15Show fewer
- Moderate or severe proteinuria
- Active infection requiring hospitalization or treatment dose medical therapy.
- Patients with ongoing wound healing problems, clinically significant wound infection requiring continued therapy or other severe surgical complication in the opinion of the Site Principal Investigator.
- Fasting Serum Cholesterol ≥300 mg/dL OR greater than or equal to 7.75 mmol/L, AND fasting triglycerides ≥2.5x the upper limit of normal (ULN). Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication, and reduction of serum cholesterol and triglyceride levels to below exclusion ranges is confirmed.
- Uncontrolled diabetes mellitus.
- Diagnosis of post-transplant lymphoproliferative disorder (PTLD) during the first 6 months post-heart transplant.
- History of non-adherence to medical regimens.
- Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) and cannot discontinue the treatment
- Patients who are pregnant or breast-feeding or intend to get pregnant during the study period.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta Emory
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
Children's of Alabama
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02115
Lurie Children's Hospital
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Health Dallas University of Texas Southwestern
Dallas, Texas, 75235
University of Florida Congenital Heart Center
Gainesville, Florida, 32610-0297
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Texas Children's Hospital
Houston, Texas, 77027
Loma Linda University
Loma Linda, California, 92354
Children's Hospital Los Angeles
Los Angeles, California, 90027
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Children's Hospital of New York
New York, New York, 10032
Stanford University
Palo Alto, California, 94304
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Children's Hospital of Pittsburgh of University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15224
Primary Children's Hospital
Salt Lake City, Utah, 84132
Seattle Children's Hospital
Seattle, Washington, 98105
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
Children's Hospital at Montefiore
The Bronx, New York, 10803
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Phase III Multicenter Open-label Randomized Clinical Trial Comparing Everolimus and Low Dose Tacrolimus to Tacrolimus and Mycophenolate Mofetil at 6 mo Post-Transplant to Prevent Long-term Complications After Pediatric Heart Transplantation
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).
Read the detailed description
Median survival after pediatric heart transplantation (HT) is 15 years in the current era. This means that a substantial fraction of patients transplanted during childhood fail to survive to adulthood, or require heart re-transplantation, because of complications related to heart transplant. These complications include heart transplant rejection, infection, coronary artery disease, post-transplant lymphoproliferative disorder (PTLD; a form of lymphoma seen in transplant recipients), and kidney failure. Most complications stem not from the heart transplant itself, but from the drugs commonly used to suppress the immune system in order to prevent rejection. In the US, tacrolimus (TAC) and mycophenolate mofetil (MMF), have emerged over the past decade as the standard of care for pediatric heart transplant immunosuppression. While pediatric survival has improved significantly in the era of TAC and MMF, post-HT complications remain a major problem that limits median survival to 15 years. Recently, everolimus (EVL) has emerged as a potential alternative immunosuppressant that may prevent rejection, coronary artery disease and kidney failure more effectively than TAC/MMF when administered in combination with low-dose tacrolimus (LDTAC). Preliminary studies suggest that EVL, and its first-generation analog sirolimus, are well tolerated in children after HT, regardless of whether it is started in response to coronary artery disease, in response to chronic kidney disease, or empirically 4-6 months after transplant in an effort to prevent the development of these complications1. However, studies are generally limited to single-center experiences using historical controls and have inadequate statistical power to demonstrate treatment differences. This will be the first multicenter randomized clinical trial of maintenance immunosuppression in pediatric heart transplantation to systematically evaluate the safety and efficacy of EVL with LDTAC vs. TAC/MMF to prevent long-term complications which lead to death/graft loss. The major adverse transplant event (MATE) score will serve as the primary endpoint to power the trial. Because no Food \& Drug Administration (FDA)-approved immunosuppressants currently exist for children after heart transplant (all prescriptions are off-label) and market incentives to support a trial are limited, the investigators have funded the trial through a Fiscal Year 2016 Peer Reviewed Medical Research Program Clinical Trial Award sponsored by the Department of Defense office of the Congressionally Directed Medical Research Programs. It is worth noting that in contrast to adults, children have a substantially longer potential life expectancy if post-transplant complications can be minimized, making the prevention of late complications an urgent priority for the pediatric heart transplant community.
- Conditions
- Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy, Heart Transplant Failure and Rejection, Post-transplant Lymphoproliferative Disorder
- Being tested
- Everolimus, Tacrolimus, Mycophenolate Mofetil
- Keywords
- heart transplantation, children, everolimus, tacrolimus, mycophenolate mofetil, randomized clinical trial
- Medical subject headings
- Renal Insufficiency, Chronic, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Zortress
Everolimus tablet
TacrolimusDrug
Also called Prograf
Tacrolimus capsule or liquid suspension
Also called Cellcept
Mycophenolate Mofetil capsule or liquid suspension
| Study group | Role | What they receive |
|---|---|---|
| Everolimus/Low-Dose Tacrolimus | Experimental | Everolimus approximately 0.6 mg/m2/dose taken by mouth every 12 hours for 30 months. Everolimus dose will be adjusted to achieve a trough concentration of 3-8 ng/ml.
Tacrolimus 0.0125 mg/kg/dose by mouth every 12 hours for 30 months. (Tacrolimus dose will be adjusted to achieve a trough concentration of 3-5 ng/ml until subjects are 1 year post-heart transplant. After 1 year post-heart transplant the tacrolimus dose will be adjusted to achieve a trough concentration of 2.5-4.5 ng/mL.) Receives: Drug: Everolimus; Drug: Tacrolimus |
| Tacrolimus/Mycophenolate Mofetil | Active comparator | Tacrolimus 0.05 mg/kg/dose by mouth every 12 hours for 30 months. (Tacrolimus dose will be adjusted to achieve a trough concentration of 7-10 ng/ml until subjects are 1 year post-heart transplant. After 1 year post-heart transplant the tacrolimus dose will be adjusted to achieve a trough concentration of 5-8 ng/mL.)
Mycophenolate mofetil 600 mg/m2/dose by mouth every 12 hours for 30 months. Receives: Drug: Tacrolimus; Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY: MATE-3 Score
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). Complete details of the score can be found in the study protocol. A higher score represents a worse outcome.
Measured: 30 months post-randomization
SAFETY: MATE-6 Score
MATE-6 is a validated score ranging from 0 to 24. The score adds together each subscore so that it 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). Complete details of the score can be found in the study protocol. A higher score represents a worse outcome.
Measured: 30 months post-randomization
Secondary outcomes (31)
Efficacy: Overall Patient Survival
Number of participants who experienced death from any cause
Measured: Up to 30 months post-randomization
Efficacy: Overall Allograft Survival
Number of participants who experienced death or heart re-transplantation
Measured: Up to 30 months post-randomization
Efficacy: Change in Kidney Function
Change in estimated glomerular filtration rate (eGFR) using the modified Schwartz equation. A positive number indicates improved kidney function, a negative number indicates worsened kidney function.
Measured: 0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization
Efficacy: Freedom From CKD Event
Number of participants who are "free from" (have NOT experienced) a chronic kidney disease MATE. A chronic kidney disease MATE was defined as an eGFR < 60 ml/min/1.73 m^2 during follow-up or worsening by at least one MATE score if < 60 ml/min/1.73 m^2 at baseline. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Efficacy: Freedom From CAV Event
Number of participants who are "free from" (have NOT experienced) cardiac allograft vasculopathy (CAV) during follow up as graded by the angiography core laboratory. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Efficacy: Freedom From BP-ACR Event
Number of participants who are "free from" (have NOT experienced) biopsy-proven Acute Cellular Rejection (ACR) MATE event during follow-up. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Efficacy: Freedom From Composite Failure
Number of participants who are "free from" (have NOT experienced) the composite of death, graft loss, 2R/3R acute cellular rejection or rejection with hemodynamic compromise. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Efficacy: EuroQOL EQ-5D Y (Youth Version)
The EuroQOL EQ-5D Y uses a visual-analog scale and asks the participant to mark an X on the line to show how good or bad your is health TODAY. The scale ranges from 0 to 100.
Measured: 30 months post-randomization
Safety: Freedom From AMR
Number of participants who are "free from" (have NOT experienced) a pathologic diagnosis of Antibody-Mediated Rejection (AMR) MATE Event. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Safety: Freedom From Infection
Number of participants who are "free from" (have NOT experienced) a serious infection MATE during follow-up. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Safety: Freedom From PTLD
Number of participants who are "free from" (have NOT experienced) a Post-Transplant Lymphoproliferative Disorder (PTLD) MATE event during follow-up. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Safety: Number of Participants Experiencing Adverse Events
Adverse events reported throughout the study. Adverse events are classified by CTCAE classification. Serious adverse events include CTCAE classes 3, 4, and 5.
Measured: From enrollment to 30 months after enrollment
Safety: Freedom From Major Transplant Events (Composite)
Number of participants who are "free from" (have NOT experienced) any MATE event, this includes chronic kidney disease, cardiac allograft vasculopathy, acute cellular rejection, antibody mediated rejection, serious infection, and post-transplant lymphoproliferative disease. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity CKD Event
Number of participants who are "free from" (have NOT experienced) a chronic kidney disease MATE of Grade 2 or greater (eGFR <45 ml/min/1.73 m^2 or on dialysis) or death due to chronic kidney disease. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity CAV Event
Number of participants who are "free from" (have NOT experienced) a cardiac allograft vasculopathy MATE of Grade 2 or greater. Grade 2 or greater is the same as having International Society of Heart and Lung Transplantation cardiac allograft vasculopathy Grade 2 or 3 or death due to cardiac allograft vasculopathy. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity ACR Event
Number of participants who are "free from" (have NOT experienced) an acute cellular rejection MATE of Grade 2 or greater. Grade 2 or greater is the equivalent of treated rejection with an assigned International Society of Heart \& Lung Transplantation acute cellular rejection grade 2 or grade 3 or rejection with hemodynamic compromise (decreased ejection fraction, need for IV medicine to support heart, need for mechanical circulatory support) or death due to acute cellular rejection. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity AMR Event
Number of participants who are "free from" (have NOT experienced) an antibody mediated rejection MATE of Grade 2 or greater. Grade 2 or greater is the equivalent of treated rejection with an assigned International Society of Heart \& Lung Transplantation antibody mediated rejection grade 2 or grade 3 or antibody mediated rejection with hemodynamic compromise (decreased ejection fraction, need for IV medicine to support heart, need for mechanical circulatory support) or death due to antibody mediated rejection. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity Infection Event
Number of participants who are "free from" (have NOT experienced) a serious infection MATE of Grade 2 or greater. Grade 2 infections require treatment with intravenous antibiotics or antivirals for 5 or more days. Grade 3 includes treatment of sepsis, endocarditis, invasive infection, or infection leading to respiratory failure. Grade 4 is death due to infection. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity PTLD Event
Number of participants who are "free from" (have NOT experienced) a post-transplant lymphoproliferative disease MATE of Grade 2 or greater. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Efficacy: Freedom From Composite of CAV, CKD, BP-ACR, or Any CMV Infection
Number of participants who are "free from" (have NOT experienced) at least one of cardiac allograft vasculopathy, chronic kidney disease with estimated glomerular filtration rate less than or equal to 60 ml/min/1.73m2, treated acute cellular rejection, or any cytomegalovirus infection. A higher number of participants on this measure indicates a better outcome.
Measured: From enrollment to 30 months after enrollment
Efficacy: Change in CKD Stage
Change in chronic kidney disease stage where improvements in CKD stage can take on a negative value.
Measured: Baseline visit through 30 months post-randomization
Efficacy: MATE-3 Score Where CKD Score is Calculated by Change From Baseline Visit
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). For this version of the score, the chronic kidney disease score is replaced by the change in MATE-CKD score from baseline visit through 30 months post-randomization. CKD change score can assume a negative value. This modified score can range from -2 to 12. A higher score represents a worse outcome.
Measured: Baseline visit through 30 months post-randomization
Efficacy: MATE-3 Score Where CKD Score is Replaced by Change in CKD Stage
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). For this version of the score, the chronic kidney disease score is replaced by the change in chronic kidney disease stage from the baseline visit through 30 months post-randomization. Chronic kidney disease stage change score can assume a negative value. This modified score can range from -2 to 12. A higher score represents a worse outcome.
Measured: Baseline visit through 30 months post-randomization
Efficacy: Composite Score Consisting of MATE CAV, MATE BP-ACR, MATE CKD Score, and Any CMV Infection.
Composite score ranging from 0 to 16. The score adds each subscore to represent the cumulative burden of three major adverse transplant events plus CMV infection. The three major adverse transplant events are Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). Any CMV infection is assigned a score of 1 with additional points using the MATE infection scoring criteria. Full details of the score can be found in the protocol. A higher score represents a worse outcome.
Measured: 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.
Composite score ranging from -2 to 16. The score adds each subscore to represent the cumulative burden of Cardiac Allograft Vasculopathy (CAV), chronic kidney disease, and Biopsy-proven Acute Cellular Rejection (ACR). Any CMV infection is assigned a score of 1 with additional points using the MATE infection scoring criteria. The chronic kidney disease MATE score is replaced by change in CKD stage. A higher score represents a worse outcome.
Measured: Baseline visit through 30 months post-randomization
Efficacy: Lansky Scores
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if < 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Measured: Baseline
Efficacy: Lansky Scores
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if < 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Measured: 18 months post-randomization
Efficacy: Lansky Scores
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if < 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Measured: 30 months post-randomization
Efficacy: Karnofsky Scores
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if >=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Measured: Baseline
Efficacy: Karnofsky Scores
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if >=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Measured: 18 months post-randomization
Efficacy: Karnofsky Scores
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if >=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Measured: 30 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start29 Jan 2018
- Primary completion17 Apr 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pediatric Heart TransplantationStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter open-label randomized clinical trial with randomization within 4 strata, defined by donor-specific antibody status and center annual transplant volume. There are 2 parallel groups of equal sizes for randomization: everolimus/low-dose tacrolimus and tacrolimus/mycophenolate mofetil.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, United States Department of Defense
- Responsible party
- Principal investigator, Kevin Daly, Boston Children's Hospital
- Investigators
- Christopher S Almond, MD, MPH, Study chair, Stanford UniversityKevin P Daly, MD, Study chair, Boston Children's HospitalLynn A Sleeper, ScD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386539
- Sponsor's protocol ID
- P00025970
- Other IDs
- PR160574, IND 127980
- Acronym
- TEAMMATE
- Status last verified
- Apr 2026
- First submitted
- 18 Dec 2017
- Last updated
- 31 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almond CS, Hoen H, Rossano JW, Castleberry C, Auerbach SR, Yang L, Lal AK, Everitt MD, Fenton M, Hollander SA, Pahl E, Pruitt E, Rosenthal DN, McElhinney DB, Daly KP, Desai M; Pediatric Heart Transplant Study (PHTS) Group Registry. Development and validation of a major adverse transplant event (MATE) score to predict late graft loss in pediatric heart transplantation. J Heart Lung Transplant. 2018 Apr;37(4):441-450. doi: 10.1016/j.healun.2017.03.013. Epub 2017 Mar 24.
PubMed 28465118Castleberry C, Ziniel S, Almond C, Auerbach S, Hollander SA, Lal AK, Fenton M, Pahl E, Rossano JW, Everitt MD, Daly KP. Clinical practice patterns are relatively uniform between pediatric heart transplant centers: A survey-based assessment. Pediatr Transplant. 2017 Aug;21(5). doi: 10.1111/petr.13013. Epub 2017 Jul 3.
PubMed 28670871Almond CS, Sleeper LA, Rossano JW, Bock MJ, Pahl E, Auerbach S, Lal A, Hollander SA, Miyamoto SD, Castleberry C, Lee J, Barkoff LM, Gonzales S, Klein G, Daly KP. The teammate trial: Study design and rationale tacrolimus and everolimus against tacrolimus and MMF in pediatric heart transplantation using the major adverse transplant event (MATE) score. Am Heart J. 2023 Jun;260:100-112. doi: 10.1016/j.ahj.2023.02.002. Epub 2023 Feb 23.
PubMed 36828201Almond CS, Daly KP, Albers EL, Alejos JC, Ameduri R, Auerbach SR, Barkoff L, Barnes AP, Bock MJ, Butto A, Carlo WF, Castleberry CD, Chrisant MR, Deshpande SR, Dreyer WJ, Everitt MD, Feingold B, Gonzales S, Hollander SA, Kindel SJ, Klein GL, Lal AK, Lamour JM, Lee J, Lu M, Lytrivi ID, Miyamoto SD, Pahl E, Peng DM, Ryan TD, Singh TP, Su JA, Sutcliffe DL, Ybarra AM, Zangwill S, Rossano JW, Sleeper LA; TEAMMATE Trial Investigators. Everolimus and Low-Dose Tacrolimus After Heart Transplant in Children: A Randomized Clinical Trial. JAMA. 2025 Oct 21;334(15):1339-1348. doi: 10.1001/jama.2025.14338.
PubMed 40960806Grimm K, Lehner A, Fernandez Rodriguez S, Orban M, Fischer M, Rosenthal LL, Jakob A, Haas NA, Dalla Pozza R, Kozlik-Feldmann R, Ulrich SM. Conversion to everolimus in pediatric heart transplant recipients is a safe treatment option with an impact on cardiac allograft vasculopathy and renal function. Clin Transplant. 2021 Mar;35(3):e14191. doi: 10.1111/ctr.14191. Epub 2020 Dec 30.
PubMed 33315277