Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients
The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS
De Novo Kidney Transplantation
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- 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.
|Study Start Date:||April 2003|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|