An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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 to assess the pharmacokinetics and relative bioavailability with and without food.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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