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NCT02444143 · ClinicalTrials.gov registry record · Phase 4
A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients
A Phase 4 study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT02444143: Completed Phase 4 study, sponsored by University of Illinois at Chicago.
NCT02444143 is a Phase 4 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02444143, a Phase 4 study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day dosing regimen. This formulation has the potential to improve compliance. Current dosing recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day administered once daily in the morning. There are no specifications on appropriate dosing in obese patients or on whether to use actual, ideal or and adjusted weight. It will be advantageous to understand the pharmacokinetics of this medication in the obese to determine the appropriate dosing regimen. In this study, obese patients will be randomized to receive tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or adjusted body weight (aBW).
Primary Outcome
Difference in tacrolimus exposure (area under the concentration-time curve from time 0 to 24 hours (AUC-0-24)) in obese patients who received an initial TAC -ER dose of 0.15 mg/kg using aBW versus IBW
Interventions
- DRUG tacrolimus extended release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-05 |
| Est. Completion | 2017-06-09 |
| Phase | Phase 4 |
What the finished NCT02444143 record still lists
NCT02444143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which tacrolimus extended release is the first listed.
NCT02444143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02444143 about?
NCT02444143 is a clinical study titled "A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients". Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day dosing regimen. This formulation has the potential to improve compliance. Current dosing recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day administered once daily in t...
What is the current status of trial NCT02444143?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2015-05. Estimated completion is 2017-06-09.
What interventions are being tested in trial NCT02444143?
The interventions under investigation include: tacrolimus extended release (DRUG).
Who is sponsoring clinical trial NCT02444143?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02444143's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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