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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03386539
The ClinicalTrials.gov registry entry for NCT03386539 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 211 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Everolimus is the first listed.
NCT03386539 reports 0 study locations.
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.
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