Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302

Novartis264 enrolled

Overview

Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of the study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF to enteric-coated mycophenolate sodium.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

264

Conditions

Renal Transplant

Interventions

Mycophenolate sodium (enteric coated)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: -First cadaveric, living unrelated or living related donor kidney transplant recipients who completed study CERL080A302 Exclusion Criteria: * Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

To assess the incidence and severity of GI adverse events (AEs) and neutropenia in the first 3 months of treatment in maintenance renal transplant patients.

Secondary Outcomes

Safety/efficacy based on adverse event (AE) reporting.

Data from ClinicalTrials.gov

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