A PHASE III, INTERNATIONAL, MULTICENTER, RANDOMISED OPEN LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB VERSUS MMF IN PATIENTS WITH CHILDHOOD ONSET IDIOPATHIC NEPHROTIC SYNDROME

Will Pendergraft, M.D., Ph.D.0 个研究点目标入组 80 人开始时间: 2023年1月22日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Diagnosis of FRNS or SDNS before the age of 18 years
•-Must be in complete remission defined by the absence of edema, UPCR =< 0.2 g/g at screening, and have three consecutive daily urine dipstick readings of trace or negative for protein within the week prior to randomization
•-Must have had at least one relapse in the 6 months prior to screening, after discontinuation of or while receiving oral corticosteroids and/or immunosuppressive therapy to prevent relapses
•-Estimated glomerular filtration rate (eGFR) within normal range for age

•-Secondary nephrotic syndrome
•-History of steroid resistant nephrotic syndrome
•-History of genetic defects known to directly cause nephrotic syndrome
•-Treatment with other immunosuppressive medications to prevent relapse, other than MMF or oral corticosteroids within 2 months prior to randomization
•-Participants demonstrating prior treatment failure to MMF as defined by two or more relapses in any 6-month period of time while receiving MMF for at least a 6-month duration
•-Participants in the judgment of the investigator likely to require systemic corticosteroids for reasons other than idiopathic nephrotic syndrome during the study

发起方

Will Pendergraft, M.D., Ph.D.