Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil
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|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|
|Actual Primary Completion Date :||April 2005|
|Actual 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.
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): NCT00238966