At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 36 enrolled
Drug / intervention
LCP-Tacro tablets +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.
Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
In Brief
A Phase 2 clinical trial evaluating LCP-Tacro tablets and Prograf for Renal Failure. Completed, enrolled 36 participants across 13 sites.
Detailed Summary
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartNov 2012
Primary CompletionMar 2013
Study CompletionMay 2013
TodayJul 2026
First PostedAug 16, 2012
Enrollment StartNov 1, 2012
Primary CompletionMar 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.9 years ago
Interventions
LCP-Tacro tabletsdrug
Tacrolimus
Prografdrug
Tacrolimus