Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil
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 Arm, Open-label Study to Investigate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Recipients Who Received Mycophenolate Mofetil (MMF)|
Resource links provided by NLM:
Drug Information available for: Mycophenolic acid Mycophenolate sodium Mycophenolate mofetil hydrochloride Mycophenolate mofetilU.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.
Secondary Outcome Measures:
- Safety based on renal function within 6 months after medication switch.
- Pharmacokinetics (PK) in a randomized subpopulation.
- Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
- Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.
- Graft survival and patient survival 6 months post medication switch.
|Study Start Date:||November 2002|
|Study Completion Date:||April 2005|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
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