Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants
This study has been completed.
Information provided by:
First received: October 12, 2005
Last updated: January 28, 2011
Last verified: January 2011
This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.
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 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|
Resource links provided by NLM:
Drug Information available for: Mycophenolic acid Mycophenolate sodium Cyclosporine Mycophenolate mofetil hydrochloride Mycophenolate mofetilU.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.
Secondary Outcome Measures:
- 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.
|Study Start Date:||February 2003|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
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