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NCT01256294 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients
A Phase 4 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
NCT01256294: Completed Phase 4 study, sponsored by Novartis.
NCT01256294 is a Phase 4 study that has completed, run by Novartis. 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
NCT01256294, a Phase 4 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
Study Summary
The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.
Primary Outcome
Dose-normalized area under the concentration-time curve from time 0 to 12 hours (AUC0-12h) at steady state after 14 days of treatment with each study drug. Geometric mean and 95% confidence intervals were determined from an analysis of variance (ANOVA) model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and patients nested within sequences as a random factor.
Interventions
- DRUG Generic Tacrolimus
- DRUG Branded Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-05 |
| Phase | Phase 4 |
What the finished NCT01256294 record still lists
NCT01256294 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 2 interventions - of which Generic Tacrolimus is the first listed.
NCT01256294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01256294 about?
NCT01256294 is a clinical study titled "Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients". The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.
What is the current status of trial NCT01256294?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2010-10. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01256294?
The interventions under investigation include: Generic Tacrolimus (DRUG), Branded Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT01256294?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01256294'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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