NCT00149864CompletedPhase 3
Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in Maintenance Renal Transplant Patients
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 264
- Primary Endpoint
- To assess the incidence and severity of GI adverse events (AEs) and neutropenia in the first 3 months of treatment in maintenance renal transplant patients.
Study Overview
Brief Summary
Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of the study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF to enteric-coated mycophenolate sodium.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •First cadaveric, living unrelated or living related donor kidney transplant recipients who completed study CERL080A302
Exclusion Criteria
- •Other protocol-defined inclusion/exclusion criteria may apply.
Outcomes
Primary Outcomes
To assess the incidence and severity of GI adverse events (AEs) and neutropenia in the first 3 months of treatment in maintenance renal transplant patients.
Secondary Outcomes
- Safety/efficacy based on adverse event (AE) reporting.
Investigators
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