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Can a new drug combo shield young hearts from transplant complications?

NCT ID NCT03386539

Disease control Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether a combination of everolimus and low-dose tacrolimus is better than the standard tacrolimus plus mycophenolate mofetil at preventing serious long-term complications in children who have had a heart transplant. The study will follow 211 participants from 25 centers for 2.5 years, measuring the cumulative burden of major adverse events like coronary artery vasculopathy, chronic kidney disease, and acute rejection. The goal is to find a regimen that improves outcomes without increasing the risk of graft loss or other complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
everolimus combined with low-dose tacrolimus, compared to tacrolimus with mycophenolate mofetil
What this could lead to
If successful, this could identify a better immunosuppressive regimen that reduces the risk of heart transplant complications, such as coronary artery vasculopathy and kidney disease, potentially improving long-term survival and quality of life for pediatric heart transplant recipients.
What could go wrong
The trial is in Phase 3 but still involves a specific pediatric population, and results may not generalize to all patients. There are risks of side effects from immunosuppressants, including increased infection risk, and the study may not show a significant difference between the two treatment groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

211 people

The number who actually took part.

Started

Jan 2018

Finished

May 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Orthotopic heart transplantation 2. Age \< 21 years at time of transplant 3. Stable immunosuppression at the time of randomization with no contraindication to everolimus, tacrolimus, or mycophenolate mofetil 4. Planned follow-up at a study site for the 30 month duration of the study. 5. Subject or legal adult representative capable of providing informed consent (in general, assent will be sought for children aged 12 years or older). Exclusion Criteria: 1. Multi-organ transplant (e.g. heart-lung or heart-liver). 2. Known hypersensitivity to everolimus, sirolimus, tacrolimus or mycophenolate mofetil (MMF), or to components of the drug products. 3. Patients on maintenance corticosteroid therapy exceeding a dose equivalent of prednisone 0.1 mg/kg/day at randomization. 4. 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 5. Graft dysfunction (LVEF \<40% or wedge pressure \>22 mmHg or cardiac index \<2.2 L/min/m2) 6. Stage 4 or 5 CKD (eGFR \<30 ml/min/1.73 m2) 7. Moderate or severe proteinuria 8. Active infection requiring hospitalization or treatment dose medical therapy. 9. 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. 10. 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. 11. Uncontrolled diabetes mellitus. 12. Diagnosis of post-transplant lymphoproliferative disorder (PTLD) during the first 6 months post-heart transplant. 13. History of non-adherence to medical regimens. 14. Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) and cannot discontinue the treatment 15. Patients who are pregnant or breast-feeding or intend to get pregnant during the study period.

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Conditions

The condition(s) this trial relates to.

chronic renal failure syndrome chronic transplant rejection post-transplant lymphoproliferative disease Rejection, Psychology transplant rejection chronic kidney disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac allograft vasculopathy Chronic kidney diseases Heart transplant failure and rejection Heart transplant infection Immunosuppression Pediatric heart transplantation Post-transplant lymphoproliferative disorder

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Health Dallas University of Texas Southwestern

    Dallas, Texas, 75235, United States

  • Children's Healthcare of Atlanta Emory

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital at Montefiore

    The Bronx, New York, 10803, United States

  • Children's Hospital of New York

    New York, New York, 10032, United States

  • Children's Hospital of Pittsburgh of University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Children's of Alabama

    Birmingham, Alabama, 35233, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021, United States

  • Loma Linda University

    Loma Linda, California, 92354, United States

  • Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84132, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Texas Children's Hospital

    Houston, Texas, 77027, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • UCLA Mattel Children's Hospital

    Los Angeles, California, 90095, United States

  • University of Florida Congenital Heart Center

    Gainesville, Florida, 32610-0297, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109, United States

  • Washington University in St. Louis School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

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