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

Phase 3

Completed

• Conditions: Renal Transplant

• Registration Number: NCT00149929
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-01
• Last Update Posted: 2011-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).