Transplantation Clinical Trial
Official title:
A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Kidney Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen
Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.
Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered
twice daily is replaced by Prograf as study medication, administered twice daily.
Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements
(see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment.
Conversion from Prograf (twice daily, morning & evening dosing) total daily dose to MR4 once
daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1.
Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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