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Immunosuppressant

Tacrolimus + Everolimus vs. Tacrolimus + MMF for Heart Transplant Care (TEAMMATE Trial)

Phase 3

Waitlist Available

Led By Lynn A Sleeper, ScD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization

Awards & highlights

TEAMMATE Trial Summary

This trial will compare two different treatments for kids who have had a heart transplant, to see which one is better at reducing the risk of problems like coronary artery disease, kidney disease, and rejection of the transplant.

Who is the study for?

This trial is for pediatric heart transplant patients under 21 years old, at least 6 months post-transplant. They must be on stable immunosuppression without contraindications to the study drugs and not pregnant or breastfeeding. Exclusions include multi-organ transplants, high rejection risk, severe kidney disease, uncontrolled diabetes, PTLD history within six months of transplant, and certain medication interactions.Check my eligibility

What is being tested?

The TEAMMATE Trial compares two drug combinations in children who've had a heart transplant: everolimus with low-dose tacrolimus versus tacrolimus with mycophenolate mofetil. It aims to see which regimen better reduces risks of artery problems, kidney disease and organ rejection over a period of 2.5 years.See study design

What are the potential side effects?

Possible side effects may include increased risk of infections due to immune system suppression; potential damage to kidneys; development of lymphoproliferative disorders; blood lipid abnormalities; wound healing complications; and possible adverse reactions specific to each drug.

TEAMMATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

EFFICACY: MATE-3 Score

SAFETY: MATE-6 Score

Secondary outcome measures

Efficacy: Change in CKD stage

Efficacy: Change in kidney function

Efficacy: Composite score consisting of MATE CAV, MATE BP-ACR, change in CKD stage, and any CMV infection.

+23 more

Side effects data

From 2017 Phase 4 trial • 60 Patients • NCT02096107

20%

Hospitalization

20%

Immunosuppression held or modified

10%

Infections

100%

80%

60%

40%

20%

Study treatment Arm

Standard of Care

Low Intensity Tacrolimus

TEAMMATE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Everolimus/Low-Dose TacrolimusExperimental Treatment2 Interventions

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.)

Group II: Tacrolimus/Mycophenolate MofetilActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Everolimus

FDA approved

Tacrolimus

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

861 Previous Clinical Trials

226,983 Total Patients Enrolled

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,519 Total Patients Enrolled

Stanford UniversityOTHER

2,388 Previous Clinical Trials

17,334,216 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals that researchers hope to achieve with this clinical trial?

"The purpose of this study, which will use a 30-month post-randomization follow-up period, is to assess efficacy via the MATE-3 Score. Additionally, safety will be measured by secondary outcomes like freedom from major transplant events and frequency/incidence of adverse events (e.g. hyperlipidemia, anemia, thrombocytopenia, interstitial lung disease)."

Answered by AI

What are some common indications for Everolimus?

"Everolimus can help patients with kidney transplant rejection, psoriasis, and waldenstrom macroglobulinemia."

Answered by AI

In how many states are hospitals participating in this research?

"To make participation as convenient as possible, this trial is enrolling at 25 sites located throughout Atlanta, Aurora, Ann Arbor and other locations. You will be able to select the location nearest you when you sign up."

Answered by AI

Is this research still looking for participants?

"The clinicaltrials.gov website says that this trial is not recruiting patients at the moment. This research project was first announced on January 29th, 2018 and has had its most recent update on September 7th, 2022. Even though this particular study isn't looking for participants, there are 902 other trials which are still actively recruiting people."

Answered by AI

What are the precedents for using Everolimus in medical research?

"As of now, there are 299 live clinical trials testing Everolimus with 38 being in Phase 3. Out of the 5214 locations running these trials, several are based in Philadelphia, Pennsylvania."

Answered by AI

When did the FDA give its stamp of approval to Everolimus?

"Everolimus ranks a 3 on Power's safety scale. This is due to the fact that it is a Phase 3 trial, indicating that there is both efficacy data as well as multiple rounds of supportive safety data."

Answered by AI

Recent research and studies

Pediatric TransplantationJournal

Clinical Practice Patterns Are Relatively Uniform Between Pediatric Heart Transplant Centers: A Survey-based Assessment

Castleberry, Chesney, Sonja Ziniel, Christopher Almond, Scott Auerbach, Seth A. Hollander, Ashwin K. Lal, Matthew Fenton, et al.. 2017. “Clinical Practice Patterns Are Relatively Uniform Between Pediatric Heart Transplant Centers: A Survey-based Assessment”. Pediatric Transplantation. Wiley. doi:10.1111/petr.13013.

Clinical TransplantationJournal

Conversion to Everolimus in Pediatric Heart Transplant Recipients Is a Safe Treatment Option with an Impact on Cardiac Allograft Vasculopathy and Renal Function

Grimm, Kathrin, Anja Lehner, Silvia Fernandez Rodriguez, Madeleine Orban, Marcus Fischer, Laura L. Rosenthal, Andre Jakob, et al.. 2020. “Conversion to Everolimus in Pediatric Heart Transplant Recipients Is a Safe Treatment Option with an Impact on Cardiac Allograft Vasculopathy and Renal Function”. Clinical Transplantation. Wiley. doi:10.1111/ctr.14191.

The Journal of Heart and Lung TransplantationJournal

Development and Validation of a Major Adverse Transplant Event (MATE) Score to Predict Late Graft Loss in Pediatric Heart Transplantation

Almond, Christopher S., Helena Hoen, Joseph W. Rossano, Chesney Castleberry, Scott R. Auerbach, Lingyao Yang, Ashwin K. Lal, et al.. 2018. “Development and Validation of a Major Adverse Transplant Event (MATE) Score to Predict Late Graft Loss in Pediatric Heart Transplantation”. The Journal of Heart and Lung Transplantation. Elsevier BV. doi:10.1016/j.healun.2017.03.013.

clinicaltrials.govStudy