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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00239070
First received: October 12, 2005
Last updated: January 28, 2011
Last verified: January 2011

October 12, 2005
January 28, 2011
April 2003
May 2006   (final data collection date for primary outcome measure)
To assess patient and graft survival, acute rejection incidence, graft function and specific pertinent safety parameters in de novo renal transplant recipients.
Not Provided
Complete list of historical versions of study NCT00239070 on ClinicalTrials.gov Archive Site
To assess the respective influence of parameters (demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications) on clinical outcomes.
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Extension Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
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

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Renal Transplantation
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
May 2006
May 2006   (final data collection date for primary outcome measure)

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

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Both
18 Years to 75 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00239070
CERL080A2405IN01E1
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Novartis
Novartis
Not Provided
Study Director: Novartis Novartis
Novartis
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP