Initial treatment of idiopathic nephrotic syndrome in children with mycophenolate mofetil vs. prednisone: A randomized, controlled, multicenter study
- Conditions
- N04.9
- Registration Number
- DRKS00006547
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 272
First episode of steroid-sensitive nephrotic syndrome (SSNS), in remission induced by prednisone 60 mg/m2 BSA per day, age at beginning of study: = 1 year and = 10 years (typical age range of patients with SSNS), ability of subject respectively the persons having care and custody of the child to understand character and individual consequences of clinical study, written informed assent of patient, if patient is =6 years of age, written informed consent of patient and the persons having care and custody of the child.
Secondary nephrotic syndrome, estimated glomerular filtration rate (eGFR) <90 ml/min x 1.73 m² BSA, ongoing treatment with systematically administered glucocorticoids or other immunosuppressive drugs at time of first episode of nephrotic syndrome, history of hypersensitivity to mycophenolate mofetil or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of suspension of mycophenolate mofetil (CellCept suspension), participation in other clinical studies or observation period of competing studies, respectively, hemoglobin concentration = 8 g/dl, leucoyte count = 2500/µl, severe chronic gastrointestinal disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of treated relapse within 24 months after end of initial treatment (non-inferiority)
- Secondary Outcome Measures
Name Time Method Course of the disease: Time from remission to first relapse; number of relapses; mean relapse rate per patient and year; incidence of frequent relapsers.<br>Prednisone-associated toxicity: Cumulative prednisone dose (mg/m² BSA); body mass index (standard deviation score); striae; hypertrichosis; acne; arterial hypertension; disturbances of carbohydrate and lipid metabolism; growth failure; cataract; glaucoma; psychological disturbances.<br>MMF-associated toxicity: diarrhea; blood cell count disturbances, infections.<br>