Status and phase
Conditions
Treatments
About
The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The study will consist of a 12-month open-label treatment period on EC-MPS.
Sex
Ages
Volunteers
Inclusion criteria
Males and females aged 18-75 years. Recipients of de novo cadaveric, living unrelated or living related kidney transplants
Exclusion criteria
Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ.
Patients who are recipients of A-B-O incompatible transplants. Patients with a historical or current peak PRA of 50%. Patients with already existing antibodies against the HLA-type of the receiving transplant.
Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin 3 times UNL).
Patients who are HIV or Hepatitis B surface antigen positive. Patients with any known hypersensitivity to mycophenolic acid, MMF, EC-MPS, other components of the formulation (e.g. lactose).
Patients with thrombocytopenia (75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.
Other protocol-defined inclusion/exclusion criteria may apply.
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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