At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 63 enrolled
Drug / intervention
cyclosporine +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.
Optima: Optimizing Prograf Therapy in Maintenance Allografts II
In Brief
A Phase 4 clinical trial evaluating cyclosporine and Prograf (Tacrolimus) for Kidney Transplantation. Completed, enrolled 63 participants across 1 site.
Detailed Summary
This study is designed to optimize calcineurin immunosuppressive regimens and evaluate immunological and non-immunological markers that may explain mechanistic differences in these agents and their effects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesUnited States
CollaboratorsAstellas Pharma US, Inc.
Timeline
Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2003
Primary CompletionJul 2008
First PostedMay 2009
TodayJul 2026
First PostedMay 20, 2009
Enrollment StartAug 1, 2003
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 17.1 years ago
Interventions
cyclosporinedrug
Maintain on cyclosporine at target trough level of 50-250 ng/mL.
Prograf (Tacrolimus)drug
Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).