Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus
Phase 3
Completed
- Conditions
- Prevention of Acute Rejection After Kidney Transplantation
- Registration Number
- NCT00171392
- Lead Sponsor
- Novartis
- Brief Summary
The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
- First or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously;
- Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);
Exclusion Criteria
Subjects expected to discontinue tacrolimus 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)