Controlled, Randomized, Parallel Group Study to Assess Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months
Study Overview
Brief Summary
The study will evaluate kidney graft function in maintenance renal transplant patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Full Dose Myfortic® and Reduced Dose Neoral®
The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
Intervention: Enteric coated mycophenolate sodium (Myfortic®) (Drug)
Standard Dose of Myfortic® and Standard Dose of CsA-ME
Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
Intervention: Enteric coated mycophenolate sodium (Myfortic®) (Drug)
Outcomes
Primary Outcomes
Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months
Time Frame: 12 months
The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.
Secondary Outcomes
- Creatinine Clearance at 12 Months(12 months)
- Serum Creatinine at 12 Months(12 months)
- Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months(12 months)
- Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months(12 months)
- Chronic Rejection as Confirmed by Renal Biopsy at 12 Months(12 months)