CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 543 enrolled
Drug / intervention
Prograf (tacrolimus) +1 moredrug
Likely dose
LCP-Tacro 0.17 mg/kgfrom 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.

Search/NCT01187953
NCT01187953Phase 3Completed
CompareCT.gov

Ph3,DB/DD,Multi-Ctr,Pros,Rand Study-Efficacy and Safety of LCP-Tacro™ Tablets, QD, Compared to Prograf® Capsules,BID, in Combination With Mycophenolate Mofetil for Acute Allograft Rejection in De Novo Kidney Transplant

Veloxis Pharmaceuticals·interventional·Posted Aug 24, 2010·Updated May 18, 2016

In Brief

A Phase 3 clinical trial evaluating Prograf (tacrolimus) and LCP-Tacro for Renal Failure. Completed, enrolled 543 participants across 86 sites in 15 countries.

Detailed Summary

This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly transplanted adult kidney transplant recipients. Patients will be treated for a 12 month study period followed by a 12 month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically similar to Prograf Capsules in the prevention of acute rejection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure
CountriesArgentina, Australia, Brazil, France, Germany, Italy, Mexico, New Zealand, Poland, Serbia, Singapore, South Korea, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 24, 2010
Enrollment StartSep 1, 2010
Primary CompletionMar 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.9 years ago

Interventions

Prograf (tacrolimus)drug

Administered per current product labeling

LCP-Tacrodrug

Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.