Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients
|ClinicalTrials.gov Identifier: NCT00239018|
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : January 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|De Novo Kidney Transplantation||Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open-label, Multicenter, Follow-up Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients|
|Study Start Date :||April 2003|
|Primary Completion Date :||July 2005|
|Study Completion Date :||July 2005|
- To assess glomerular filtration rate at month 3 post transplantation
- Renal function of patients requiring post transplantation dialysis, experiencing slow graft function (defined as S. Creat level>264 μmol/l at D5) or with immediate graft function.
- Incidence of patients requiring post transplantation dialysis, experience slow graft function (defined as S. Creat level>264 μmol/l at D5 or with immediate graft function.
- Incidence of biopsy proven acute rejection, any treated acute rejection, and any treated acute rejection requiring antibody therapy, recurrent acute rejection and the severity of acute rejection episodes within 6 and 12 months
- Incidence of graft and patient survival within 6 and 12 months
- Safety and tolerability based on adverse event (AE) reporting.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239018