Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium After Equimolar Conversion From Mycophenolate Mofetil (MMF) in Patients With Renal Transplant
Phase 3
Completed
- Conditions
- Prevention of Acute Rejection After Kidney Transplantation
- Registration Number
- NCT00171379
- Lead Sponsor
- Novartis
- Brief Summary
The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
Inclusion Criteria
-
First or second (single or double) deceased or living donor kidney transplant received at least six months previously;
- Immunosuppressive therapy with cyclosporin and mycophenolate mofetil (MMF);
- Receiving an MMF dose of <2/g/day because of any adverse event and/or altered laboratory test result attributed to MMF
Exclusion Criteria
-
• Subjects expected to discontinue cyclosporin therapy;
- Patients with thrombocytopenia (<75,000/mm3), an absolute neutrophil count of <1,500/mm3 and/or leukopenia (<2,500/mm3), or anemia (hemoglobin <6 g/dl) at baseline;
- Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia >2.5 mg/dL) or worsening renal function in the previous two months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula
- Secondary Outcome Measures
Name Time Method Incidence of biopsy proven acute rejection Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms) Quality of life related to GI symptoms (GIQLI scale) Full blood count Gastrointestinal Adverse Events (check-list)