A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)
Phase 4
Completed
- Conditions
- Renal Transplantation
- Registration Number
- NCT00238979
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Tolerability based on adverse events within 6 months after switch from MMF to an optimized enteric-coated mycophenolate sodium regimen.
- Secondary Outcome Measures
Name Time Method Safety based on renal function within 6 months after medication switch. Pharmacokinetics of enteric-coated mycophenolate sodium in combination with tacrolimus in a subpopulation at baseline, week 2, month 3 Influence of enteric-coated mycophenolate sodium on the activity of an enzyme at baseline, week 2, month 3 Incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch. Graft survival and patient survival 6 months post medication switch.