CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 850 enrolled
Drug / intervention
FK506Edrug
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/NCT02118896
NCT02118896Phase 3Completed
CompareCT.gov

A Long-term Follow up Study to Evaluate the Safety and Efficacy in Transplant Recipients Treated With Modified Release Tacrolimus, FK506E (MR4), Based Immunosuppression Regimen

Astellas Pharma Europe Ltd.·interventional·Posted Apr 21, 2014·Updated Nov 22, 2024

In Brief

A Phase 3 clinical trial evaluating FK506E for Heart Transplantation and 2 related conditions. Completed, enrolled 850 participants across 105 sites in 23 countries.

Detailed Summary

The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Transplantation, Liver Transplantation, Kidney Transplantation
CountriesAustralia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Mexico, Netherlands, New Zealand, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 21, 2014
Enrollment StartFeb 24, 2003
Primary CompletionOct 7, 2009
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 12.2 years ago

Interventions

FK506Edrug

oral