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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 is a Phase 4 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 20 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02444143
The ClinicalTrials.gov registry entry for NCT02444143 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which tacrolimus extended release is the first listed.
NCT02444143 reports 0 study locations.
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.
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