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

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