Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

Phase 4

Completed

• Conditions: Renal Transplantation
• Interventions: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

• Registration Number: NCT00241059
• Lead Sponsor: Novartis

Brief Summary

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-28
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

• All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Exclusion Criteria

• Other protocol-defined inclusion / exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EC-MPS arm	Enteric-Coated Mycophenolate Sodium (EC-MPS)	-

Primary Outcome Measures

Name	Time	Method
Safety parameters and graft function in maintenance renal transplant recipients.

Secondary Outcome Measures

Name	Time	Method
Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.