Transplantation
Conditions
Keywords
Tacrolimus, Liver Transplantation
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.
Interventions
DRUGTacrolimus
Immunosuppression
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Liver 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.
Exclusion criteria
* Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Creatinine clearance | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure, HbA1c, Acute rejection episodes | 12 weeks |
Countries
France, Germany, Ireland, Poland, Spain, United Kingdom
Outcome results
None listed