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NCT00282256 · ClinicalTrials.gov registry record · Phase 2
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
A Phase 2 study, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT00282256: Completed Phase 2 study, sponsored by Astellas Pharma.
NCT00282256 is a Phase 2 study that has completed, run by Astellas Pharma. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00282256, a Phase 2 study, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
Primary Outcome
The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state using the linear trapezoidal rule. The AUC0-24 for tacrolimus was calculated as the sum of the AUC0-12 and AUC 12-24 for the morning and afternoon doses.
Interventions
- DRUG tacrolimus
- DRUG tacrolimus modified release (MR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2004-01 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00282256 record still lists
NCT00282256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which tacrolimus is the first listed.
NCT00282256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00282256 about?
NCT00282256 is a clinical study titled "A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients". A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
What is the current status of trial NCT00282256?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2004-01. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00282256?
The interventions under investigation include: tacrolimus (DRUG), tacrolimus modified release (MR) (DRUG).
Who is sponsoring clinical trial NCT00282256?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00282256's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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