At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 70 enrolled
Drug / intervention
Tacrolimus Modified Release (MR) +1 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.
A Phase 2, Open-Label, Multi-center Study to Assess the Pharmacokinetics, Safety and Tolerability of Tacrolimus in Stable Kidney Transplant Patients Converted From a Prograf® Based Immunosuppression Regimen to a Modified Release (MR) Tacrolimus Based Immunosuppression Regimen
In Brief
A Phase 2 clinical trial evaluating Tacrolimus Modified Release (MR) and tacrolimus for Kidney Transplantation. Completed, enrolled 70 participants across 9 sites in 2 countries.
Detailed Summary
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2002
First PostedJan 2006
Primary CompletionOct 2008
TodayJul 2026
First PostedJan 27, 2006
Enrollment StartAug 1, 2002
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 20.4 years ago
Interventions
Tacrolimus Modified Release (MR)drug
Oral
tacrolimusdrug
Oral