Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00149929|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant||Drug: Mycophenolate sodium (enteric coated)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||246 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in de Novo Renal Transplant Patients|
|Study Start Date :||December 1999|
|Actual Primary Completion Date :||April 2003|
|Actual Study Completion Date :||April 2003|
- Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment.
- Incidence of biopsy proven acute rejection in the first six months of treatment in de novo renal transplant recipients.
- Efficacy of enteric-coated mycophenolate sodium
- Safety of enteric-coated mycophenolate sodium based on AE reporting.
- Pharmacokinetics (PK) of enteric-coated mycophenolate sodium (selected centers only).
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): NCT00149929