Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01005316 · ClinicalTrials.gov registry record
Alloantibodies in Pediatric Heart Transplantation
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- 290
- Enrollment target
NCT01005316: Clinical Trial study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01005316 is a clinical trial that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 290 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01005316 was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- 290 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the clinical outcomes of sensitized pediatric heart transplant recipients with a positive donor-specific cytotoxicity crossmatch and to compare this group with outcomes in nonsensitized heart transplant recipients.
Primary Outcome
This is a composite outcome of death, graft loss or rejection with hemodynamic compromise. Rejection was considered to be with hemodynamic compromise if the rejection event had new onset echocardiographically measured from fractional shortening \<26% with ≥5% fall from last echocardiogram or the rejection event had new onset of heart failure.
Interventions
- DRUG Mycophenolate Mofetil
- DRUG Tacrolimus
- DRUG Induction Therapy
- PROCEDURE Intraoperative plasma exchange/pheresis
- PROCEDURE Short-term post-operative plasmapheresis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-12 |
Why NCT01005316 stopped before completion
NCT01005316 is an observational study that tracks outcomes without assigning an intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT01005316 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01005316 about?
NCT01005316 is a clinical study titled "Alloantibodies in Pediatric Heart Transplantation". The purpose of this study is to determine the clinical outcomes of sensitized pediatric heart transplant recipients with a positive donor-specific cytotoxicity crossmatch and to compare this group with outcomes in nonsensitized heart transplant recipients.
What is the current status of trial NCT01005316?
This trial is currently terminated. The enrollment target is 290 participants. The study started on 2010-01. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01005316?
The interventions under investigation include: Mycophenolate Mofetil (DRUG), Tacrolimus (DRUG), Induction Therapy (DRUG), Intraoperative plasma exchange/pheresis (PROCEDURE), Short-term post-operative plasmapheresis (PROCEDURE).
Who is sponsoring clinical trial NCT01005316?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00775476 · 290 participants · Phase 2
Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine
- NCT01874197 · 290 participants · NA
Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic
- NCT04331353 · 290 participants · NA
The Allergen Reduction and Child Health Study (ARCHS)
- NCT04649008 · 290 participants · Early Phase 1
Localizing Epileptic Networks Using MRI and iEEG
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia