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NCT03386539 · ClinicalTrials.gov registry record · Phase 3
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
A Phase 3 study, sponsored by Boston Children's Hospital.
- Active
- Registry status
- Phase 3
- Development phase
- 211
- Enrollment target
NCT03386539: Active Phase 3 study, sponsored by Boston Children's Hospital.
NCT03386539 is a Phase 3 study that is active but no longer recruiting, run by Boston Children's Hospital. The registered enrollment target is 211 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03386539, a Phase 3 study, is active but no longer recruiting, sponsored by Boston Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 211 participants
- Enrollment target
Study 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. 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).
Primary Outcome
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.
Interventions
- DRUG Everolimus
- DRUG Mycophenolate Mofetil
- DRUG Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2018-01-29 |
| Est. Completion | 2024-01 |
| Phase | Phase 3 |
What the registry record for NCT03386539 still lists
NCT03386539 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Everolimus is the first listed.
NCT03386539 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03386539 about?
NCT03386539 is a clinical study titled "Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score". 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...
What is the current status of trial NCT03386539?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2018-01-29. Estimated completion is 2024-01.
What interventions are being tested in trial NCT03386539?
The interventions under investigation include: Everolimus (DRUG), Mycophenolate Mofetil (DRUG), Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT03386539?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03386539's enrollment target sits among peer trials
211 1337th of 2000 higher than 663 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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