At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 73 enrolled
Drug / intervention
Prograf +1 moredrug
Likely dose
Prograf 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.
Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients
In Brief
A Phase 4 clinical trial evaluating Prograf and Tacrolimus Hexal for Pharmacokinetics Study in de Novo Kidney Transplantation. Completed, enrolled 73 participants across 5 sites.
Detailed Summary
The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure resulted in similar renal function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartOct 2012
Primary CompletionAug 2015
TodayJul 2026
First PostedJul 25, 2012
Enrollment StartOct 17, 2012
Primary CompletionAug 20, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.9 years ago
Interventions
Prografdrug
Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths.
Tacrolimus Hexaldrug
Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg, 1 mg and 1.5 mg.