Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00241059|
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : January 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplantation||Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||183 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
|Experimental: EC-MPS arm||
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Safety parameters and graft function in maintenance renal transplant recipients.
- Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241059
|Study Director:||Novartis Pharmaceuticals||Novartis|