Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301

Novartis246 enrolled

Overview

Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

246

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 human antigen mismatched living related donor kidney transplant recipients who completed study CERL080A301 Exclusion Criteria: * Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment.

Secondary Outcomes

Incidence of biopsy proven acute rejection in the first six months of treatment in de novo renal transplant recipients.

Efficacy of enteric-coated mycophenolate sodium

Safety of enteric-coated mycophenolate sodium based on AE reporting.

Pharmacokinetics (PK) of enteric-coated mycophenolate sodium (selected centers only).

Data from ClinicalTrials.gov

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