At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 50 enrolled
Drug / intervention
LCP-Tacro +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Rand, Open-label, Single-center, 2 Sequence, 3 Period Crossover Study to Compare the Steady State PK of Once-Daily-Extended Release LCP-Tacro to Generic Tacrolimus Capsules Twice Daily in Stable A A Renal Transplant pt.
In Brief
A Phase 3 clinical trial evaluating LCP-Tacro and Tacrolimus -IR for Renal Failure. Completed, enrolled 50 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 2013
Enrollment StartNov 2013
Primary CompletionJul 2015
Study CompletionAug 2015
TodayJul 2026
First PostedOct 14, 2013
Enrollment StartNov 1, 2013
Primary CompletionJul 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.7 years ago
Interventions
LCP-Tacrodrug
once-daily extended release tablet
Tacrolimus -IRdrug
twice daily capsules