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

Phase 3

Completed

• Conditions: Renal Transplant
• Interventions: Drug: Mycophenolate sodium (enteric coated)

• Registration Number: NCT00149916
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04
• Primary Completion: 2004-04
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• Cadaveric or living donor kidney transplant recipients who completed the study CERL080A0107

Exclusion Criteria

• Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mycophenolate sodium (enteric coated)	Mycophenolate sodium (enteric coated)	-

Primary Outcome Measures

Name	Time	Method
To assess gastro-intestinal tolerability

Secondary Outcome Measures

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