Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301
|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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149929