Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients
Condition: Stable Renal Transplant Recipients
Intervention: mycophenolate mofetil (Myfenax); mycophenolate mofetil (Cellcept)
Intervention description: Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'T' (test drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.; Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'R' (reference drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: renal transplantation; mycophenolate mofetil; pharmacokinetics; immunosuppression

Summary:

      The purpose of the study is to further investigate how much of the drug substance
      "mycophenolate mofetil" can be found in the blood of patients with kidney or renal
      transplants when treated with Myfenax® or CellCept®. Additionally, the safety and side
      effects of the two products will be compared. All information already available on these
      products indicates that the safety profiles of the two products will be the same.
    

Eligibility criteria:

        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.