Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants
|ClinicalTrials.gov Identifier: NCT00238940|
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 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A One-year, Randomized, Open Label, Parallel Group Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Either Full Dose or Reduced Dose Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients|
|Study Start Date :||February 2003|
|Primary Completion Date :||September 2005|
|Study Completion Date :||September 2005|
- Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.
- Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.
- Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation
- Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup
- Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.
- Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238940