Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy
|ClinicalTrials.gov Identifier: NCT00149942|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation Liver Transplantation||Drug: Enteric-coated Mycophenolate sodium (EC-MPS)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From GI Adverse Events While on Mycophenolate Mofetil Therapy|
|Study Start Date :||October 2004|
|Primary Completion Date :||August 2006|
|Study Completion Date :||August 2006|
- Gastro-intestinal adverse events before switch versus 3 months after switch
- Time to the first biopsy-proven rejection after conversion.
- Severity of biopsy-proven rejections after conversion.
- Proportion of patients who had graft loss after conversion.
- Frequency of adverse events
- Frequency of infections
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149942