A Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

Novartis0 sites69 target enrollmentStarted: April 1, 2003Last updated: January 31, 2011

Conditions

Drugs

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor: Novartis
Enrollment: 69
Primary Endpoint: To assess patient and graft survival, acute rejection incidence, graft function and specific pertinent safety parameters in de novo renal transplant recipients.

Study Overview Study Design Eligibility Criteria Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

This extension study is to assess the long-term safety of EC-MPS

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Single Group
Primary Purpose: Prevention
Masking: None

Eligibility Criteria

Ages: 18 Years to 75 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Inclusion /

Exclusion Criteria

•All patients who completed study CERL080A2405-IN01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.
•Other protocol-defined inclusion / exclusion criteria may apply

Outcomes

Primary Outcomes

To assess patient and graft survival, acute rejection incidence, graft function and specific pertinent safety parameters in de novo renal transplant recipients.

Secondary Outcomes

To assess the respective influence of parameters (demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications) on clinical outcomes.

Investigators

Sponsor

Novartis

Sponsor Class

Industry

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