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NCT02014103 · ClinicalTrials.gov registry record · Phase 4
Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients
A Phase 4 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
NCT02014103: Completed Phase 4 study, sponsored by University of Cincinnati.
NCT02014103 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 71 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02014103, a Phase 4 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
Study Summary
The prospective study will compare the relative bioavailability at steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.
Primary Outcome
Report the geometric mean and 95% confidence interval for AUC 0-12hr (ng\*hr/ml) for each formulation in expressor and non expressor transplant recipients
Interventions
- DRUG Prograf
- DRUG Tacrolimus, Sandoz
- DRUG Tacrolimus, Reddy Laboratory
- DRUG Tacrolimus, Mylan
- DRUG Tacrolimus, Accord
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2015-03 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
What the finished NCT02014103 record still lists
NCT02014103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 5 interventions - of which Prograf is the first listed.
NCT02014103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02014103 about?
NCT02014103 is a clinical study titled "Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients". The prospective study will compare the relative bioavailability at steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.
What is the current status of trial NCT02014103?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2015-03. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02014103?
The interventions under investigation include: Prograf (DRUG), Tacrolimus, Sandoz (DRUG), Tacrolimus, Reddy Laboratory (DRUG), Tacrolimus, Mylan (DRUG), Tacrolimus, Accord (DRUG).
Who is sponsoring clinical trial NCT02014103?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02014103's enrollment target sits among peer trials
71 1040th of 2000 higher than 958 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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