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NCT01889758 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetic Studies of Tacrolimus in Transplant Patients
A Phase 4 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 78
- Enrollment target
NCT01889758: Completed Phase 4 study, sponsored by University of Cincinnati.
NCT01889758 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 78 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01889758, a Phase 4 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 78 participants
- Enrollment target
Study Summary
The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and the two most disparate generic formulations (Generic Hi and Generic Lo) in a fully replicated, 3-way cross-over study in stable kidney (n=36) and liver transplant (n=36) subjects.
Primary Outcome
Ratio of C0, C12, AUC0-12h and Cmax and apply confidence interval (CI) testing at steady state of Prograf to generic Hi in stable kidney and liver transplant subjects
Interventions
- DRUG Tacrolimus
- DRUG Prograf
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2013-06 |
| Est. Completion | 2016-01 |
| Phase | Phase 4 |
What the finished NCT01889758 record still lists
NCT01889758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus is the first listed.
NCT01889758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01889758 about?
NCT01889758 is a clinical study titled "Pharmacokinetic Studies of Tacrolimus in Transplant Patients". The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and the two most disparate generic formulations (Generic Hi and Generic Lo) in a fully replicated, 3-way cross-over study in stable kidney (n=36) and liver transplant (n=36) subjects.
What is the current status of trial NCT01889758?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 78 participants. The study started on 2013-06. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01889758?
The interventions under investigation include: Tacrolimus (DRUG), Prograf (DRUG).
Who is sponsoring clinical trial NCT01889758?
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 NCT01889758's enrollment target sits among peer trials
78 982nd of 2000 higher than 1,012 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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