An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients
Phase 3
Completed
- Conditions
- Kidney Transplant Recipients
- Registration Number
- NCT00239044
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen .
- Secondary Outcome Measures
Name Time Method Pharmacokinetic profiles of MMF and EC-MPS. Patient and graft survival, graft function Safety