Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Phase 4

Completed

• Conditions: De Novo Kidney Transplant Recipients

• Registration Number: NCT00312143
• Lead Sponsor: Novartis

Brief Summary

This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney transplant recipients.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Study First Submitted: 2006-04-05
• Study First Submitted QC: 2006-04-05
• Study First Posted: 2006-04-07
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-01
• Last Update Posted: 2011-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
patient and graft survival
acute rejection incidence
graft function at 6 months post transplant.

Secondary Outcome Measures

Name	Time	Method
influence of age, gender, and post-transplantation complications on the main clinical outcomes