Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) Plus Valsartan in Patients With Kidney Transplants (MYTHOS
Phase 3
Completed
- Conditions
- De Novo Renal Transplantation
- Registration Number
- NCT00308425
- Lead Sponsor
- Novartis
- Brief Summary
The primary aim of this study is to evaluate the safety and efficacy of EC-MPS plus valsartan as part of an intensified multifactorial intervention on the reduction of the 12-month rate of transplant nephropathy compared with EC-MPS plus standard practice of care in recipients of a first cadaver donor kidney transplant given CsA-ME, basiliximab, and short-term steroids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 12-month rate of success in preventing relapse of nephropathy, defined as persistent albumin excretion rate (AER) > 300 mg/24h and safety, compared between groups.
- Secondary Outcome Measures
Name Time Method Renal function, as measured by serum creatinine and calculated creatinine clearance after 6 and 12 months; Glomerular filtration rate (GFR), as plasma clearance of unlabeled iohexol, after 6 and 12 months; Albumin excretion rate and fractional clearance of albumin after 6 and 12 months; Fasting blood glucose levels, total cholesterol, triglyceride and HDL levels and systolic and diastolic blood pressure after 6 and 12 months; Incidence of acute rejection after 6 and 12 months; Patient and graft survival at 12 months;