Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil
|ClinicalTrials.gov Identifier: NCT00238966|
Recruitment Status : Completed
First Posted : October 14, 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 :||187 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A One Arm, Open-label Study to Investigate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Recipients Who Received Mycophenolate Mofetil (MMF)|
|Study Start Date :||November 2002|
|Primary Completion Date :||April 2005|
|Study Completion Date :||April 2005|
- Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.
- Safety based on renal function within 6 months after medication switch.
- Pharmacokinetics (PK) in a randomized subpopulation.
- Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
- Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.
- Graft survival and patient survival 6 months post medication switch.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238966