Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients
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Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.
Efficacy of EC-MPS compared to MMF in Chinese patients as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant recipients.
Secondary Outcome Measures
Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients
Other variables of efficacy: chronic rejection, graft loss, death.
Safety of EC-MPS as measured by incidence of adverse events and serious adverse events.
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant,
treated with cyclosporine and corticosteroids as primary immunosuppression.
Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ
Patients who have received an investigational drug within four weeks prior to study entry
Other protocol-defined inclusion/exclusion criteria may apply.