Initial treatment of idiopathic nephrotic syndrome in children with mycophenolate mofetil vs. prednisone: A randomized, controlled, multicenter study - INTENT study

niversitätsklinikum Heidelberg0 个研究点目标入组 272 人开始时间: 2017年2月24日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

发起方

niversitätsklinikum Heidelberg