Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants
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|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|
|Actual Primary Completion Date :||September 2005|
|Actual 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.
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): NCT00238940