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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: Completed Phase 3 study of Renal Failure, sponsored by Veloxis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
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 |
What the finished NCT01962922 record still lists
NCT01962922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 297-participant average among 11 other Renal Failure trials with a reported enrollment target (83% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Renal Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01962922's enrollment target sits among peer trials
50 6th of 11 higher than 6 of 11 other Renal Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Failure 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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