At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 71 enrolled
Drug / intervention
Generic Tacrolimus +1 moredrug
Likely dose
Generic Tacrolimus 0.5 mgfrom 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.
A Prospective, Multi-center, Open-label, Randomized, Two Period, Two Sequence, Crossover Study to Compare the Steady State Pharmacokinetics of Generic Tacrolimus (Sandoz) to Prograf in Stable Renal Transplant Patients
In Brief
A Phase 4 clinical trial evaluating Generic Tacrolimus and Branded Tacrolimus for Renal Transplant. Completed, enrolled 71 participants across 2 sites.
Detailed Summary
The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplant
CountriesUnited States
CollaboratorsSandoz
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2010
First PostedDec 2010
Primary CompletionMay 2011
TodayJul 2026
First PostedDec 8, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.6 years ago
Interventions
Generic Tacrolimusdrug
Generic Sandoz tacrolimus supplied as capsules of 0.5 mg, 1 mg and 5 mg dose strengths.
Branded Tacrolimusdrug
Capsules supplied at dose strengths of 0.5 mg, 1 mg, and 5 mg.