Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107

Novartis Pharmaceuticals139 enrolled

Overview

Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate sodium in regard to adverse events, serious adverse events and patient and graft survival. After successful completion of the study CERL080A0107 study, patients could continue to receive enteric-coated mycophenolate sodium.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

139

Conditions

Renal Transplant

Interventions

Mycophenolate sodium (enteric coated)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Cadaveric or living donor kidney transplant recipients who completed the study CERL080A0107 Exclusion Criteria: * Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

To assess gastro-intestinal tolerability

Secondary Outcomes

Efficacy/safety of enteric-coated mycophenolate sodium based on AE reporting.

Data from ClinicalTrials.gov

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