A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
- Registration Number
- NCT00384137
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- Kidney transplant at least 12 months prior to enrollment.
- Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.
- Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Tacrolimus -
- Primary Outcome Measures
Name Time Method Creatinine clearance 12 weeks
- Secondary Outcome Measures
Name Time Method Blood pressure, HbA1c, acute rejection 12 weeks