Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients

Novartis Pharmaceuticals300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Renal Transplant

Interventions

Mycophenolate sodium (enteric coated)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

General Hospital, Friendship Hospital, Beijing, No 1 Hospital Peking University, Beijing China; Shanghai No 1 Hospital, Shanghai China; Changzheng Hospital, Shanghai, China; Shanghai Ruij

Beijing, China

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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