Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT00384202
Brief Summary:
Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.
Detailed Description:
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.
Study:
NCT00384202
Study Brief:
Protocol Section:
NCT00384202