Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients

Inclusion Criteria:

• Renal transplant recipients at least 12 months post-transplantation aged ≥ 18 years.
• Maintenance treatment with mycophenolate mofetil (in combination with tacrolimus with or without corticosteroids).
• Stable dose of mycophenolate mofetil (≥ 500 mg twice daily) with no changes in immunosuppressive regimen for at least 6 weeks prior to the start of the study.
• Stable renal graft function for at least 3 months.
• Female patients must be either post-menopausal for ≥ 1 year, be surgically sterilized or a negative pregnancy test will be required immediately prior to study entry and such patients must continue to use effective contraception.
• Willingness to undergo the study-related procedures.
• Ability to comprehend and willingness to sign informed consent form.

Exclusion Criteria:

• History of allergy to mycophenolate mofetil, mycophenolic acid or any of the ingredients.
• Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any organ other than kidney.
• Rejection within the past 6 months prior to the start of the study.
• Severe clinically relevant co-existing disease.
• History of cancer other than skin cancer that has been cured.
• History of serious clinically relevant digestive system disease during the last 12 months prior to start of the study.
• Known or suspected hereditary deficiency of hypoxanthine-guanine-phosphoribosyltransferase (e.g., Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome).
• Known or suspected liver impairment.
• Clinically significant thrombocytopenia, anaemia, leukopenia, or neutropenia
• Clinically significant laboratory and/or physical changes during the last 2 months prior to the start of the study.
• Use of azathioprine, cholestyramine, sevelamer, or probenecid within 2 weeks prior to the first administration of study medication.
• Change in concomitant medication during the 6 weeks prior to start of the study.
• Use of any drug, prescribed or over-the-counter, (except stable concomitant medication) within 2 weeks prior to the first administration of study medication.
• Planned or expected requirement for the use of live attenuated vaccines during the study.
• Positive testing for HIV, Hepatitis B and C.
• Clinical symptoms or laboratory evidence of cytomegalovirus infection in the last 6 month.
• Pregnant or breast-feeding women.
• Women of childbearing potential unable or unwilling to practice effective contraceptive measures for the duration of the study and for 6 weeks after the end of the study.
• History of known or suspected alcohol or drug abuse.
• Any other condition of the patient that, in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient's compliance or adherence to protocol requirements.
• Previous enrollment in this study or participation in any other drug investigational trial within the past 6 weeks prior to enrollment.