Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil

Phase 4

Completed

• Conditions: Renal Transplantation

• Registration Number: NCT00238966
• Lead Sponsor: Novartis

Brief Summary

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-14
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-28
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.

Secondary Outcome Measures

Name	Time	Method
Safety based on renal function within 6 months after medication switch.
Pharmacokinetics (PK) in a randomized subpopulation.
Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.
Graft survival and patient survival 6 months post medication switch.