CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 71 enrolled
Drug / intervention
Prograf +5 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.

Search/NCT02014103
NCT02014103Phase 4Completed

Evaluation of Clinical and Safety Outcomes Associated With Conversion From Brand-Name to Generic Tacrolimus Products in High Risk Transplant Recipients

University of Cincinnati·interventional·Posted Dec 18, 2013·Updated Oct 15, 2024

In Brief

A Phase 4 clinical trial evaluating Prograf, Tacrolimus, Sandoz, and 4 other interventions for Complication of Transplant. Completed, enrolled 71 participants across 1 site.

Detailed Summary

The prospective study will compare the relative bioavailability at steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 18, 2013
Enrollment StartMar 1, 2015
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.5 years ago

Interventions

Prografdrug

Administration of each formulation will be determined by sequence.

Tacrolimus, Sandozdrug

Administration of each formulation will be determined by sequence.

Tacrolimus, Reddy Laboratorydrug

Administration of each formulation will be determined by sequence.

Tacrolimus, Mylandrug

Administration of each formulation will be determined by sequence.

Tacrolimus, Accorddrug

Administration of each formulation will be determined by sequence.

Tacrolimus, Pancea Biotech Limiteddrug

Administration of each formulation will be determined by sequence.