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NCT01962922 · ClinicalTrials.gov registry record · Phase 3
Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.
A Phase 3 study of Renal Failure, sponsored by Veloxis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 3
- Study locations
NCT01962922 is a Phase 3 study of Renal Failure that has completed, run by Veloxis Pharmaceuticals. The registered enrollment target is 50 participants, below the 297-participant average among 11 other Renal Failure trials with a reported enrollment target (83% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT01962922, a Phase 3 study of Renal Failure, has completed, sponsored by Veloxis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 3
- Study locations
Study Summary
Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable African-American renal transplant patients.
Conditions Studied
Interventions
- DRUG LCP-Tacro
- DRUG Tacrolimus -IR
Study Locations (3)
Illinois
- University of Illinois, Chicago - Chicago
Missouri
- Washingto University School of Medicine - St Louis
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01962922
The ClinicalTrials.gov registry entry for NCT01962922 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 297-participant average among 11 other Renal Failure trials with a reported enrollment target (83% lower). The listed sponsor is Veloxis Pharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Renal Failure appearing as the primary indexed condition, and to 2 interventions - of which LCP-Tacro is the first listed.
NCT01962922 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Illinois, Missouri, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01962922 about?
NCT01962922 is a clinical study titled "Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.". Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable African-American renal transplant patients.
What is the current status of trial NCT01962922?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2013-11. Estimated completion is 2015-08.
What conditions does trial NCT01962922 study?
This clinical trial studies the following conditions: Renal Failure.
What interventions are being tested in trial NCT01962922?
The interventions under investigation include: LCP-Tacro (DRUG), Tacrolimus -IR (DRUG).
Who is sponsoring clinical trial NCT01962922?
This trial is sponsored by Veloxis Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01962922 being conducted?
This trial has 3 study locations across Illinois, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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