Status:
COMPLETED
An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant Recipients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effect of food on the oral bioavailability of tacrolimus modified release (MR4) capsules together with a standard continental breakfast. The objective is t...
Detailed Description
Stable kidney transplant recipients who are participating in the clinical trial FG-506-14-02 and who are currently being treated with FK506E (MR4) under fasted conditions and who have had no changes i...
Eligibility Criteria
Inclusion
- Stable kidney transplant patient aged ≥ 18 years who is participating in clinical trial FG-506-14-02 and is being treated with FK506E (MR4)
- The total daily dose of each immunosuppressive medication, including FK506E (MR4), or any other concomitant medication has remained unchanged for at least seven days prior to enrolment
- Patient has a serum creatinine level \< 265 μmol/L at enrolment
- Female patient of childbearing potential must have a negative serum or urine pregnancy test prior to enrolment and must have agreed to practice effective birth control during the study
Exclusion
- Patient had previously received an organ transplant other than kidney
- Patient with any form of substance abuse, psychiatric disorder or condition which may complicate communication with the investigator
- Patient had experienced any rejection episode within 90 days prior to enrolment, any rejection episode within the last six months that had required anti-lymphocyte antibody therapy or more than two rejection episodes within the last 12 months
- Patient has a chronic dysfunction of the kidney
- Patient had major changes in her/his immunosuppressive regimen within the last three months prior to enrolment
- Patient has significant liver disease, defined as having elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels (at least two times the upper value of the normal range at the investigational site) during the 28 days prior to enrolment
- Patient receives insulin therapy
- Patient requires treatment with medication or substances known to interfere with tacrolimus metabolism or having taken such medication within 28 days prior to enrolment and during participation
- Patient had any unstable medical condition that could interfere with the study
- Patient is pregnant or a breast-feeding mother
- Patient is known to be positive for HIV
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00865137
Start Date
September 1 2007
End Date
December 1 2007
Last Update
July 18 2014
Active Locations (1)
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1
Maastricht, Netherlands, 6229 HX