A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)
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The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.
A 6-month, 1-arm, Open-label Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Recipients of first or secondary cadaveric heart-beating, living unrelated or living related kidney transplant.
Currently receiving 1, 1.5, or 2 g MMF/day, tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months.
In a stable condition in terms of graft function.
Patients who had taken an investigational drug within four weeks prior to study entry
History of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
Thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<2,500/mm3), and/or hemoglobin <6.0 g/dL prior to enrollment
Clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, evidence of severe liver disease, HIV or Hepatitis B surface antigen positive.
Other protocol-defined inclusion/exclusion criteria may apply.