Efficacy of rituximab in comparison to continued corticosteroid treatment in idiopathic nephrotic syndrome unresponsive to 8 weeks of high dose prednisone. - Rituximab in SRNS

Radboud University Nijmegen Medical Center0 个研究点目标入组 40 人开始时间: 2017年10月10日最近更新: 2018年1月8日

试验速览

暂无简介。

•Age = 18 years
•Persistent proteinuria = 2 g/ 24 hours or a protein-to-creatinine ratio = 2 g/10mmol (2 g/g) after 8 weeks of treatment with high dose prednisone 1 mg/kg/day (max 80 mg/day)
•Idiopathic nephrotic syndrome caused by biopsy proven minimal change disease or focal segmental glomerulosclerosis
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Severe nephrotic syndrome with hypotension
•Previous treatment with immunosuppressive medication other than prednisone
•Treatment with prednisone > 10 weeks in last six months
•Secondary form of FSGS or minimal change disease
•Patients who test positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody
•(anti-HBc).
•Patients infected with HIV or suffering from other active infections
•Patients inoculated with a live vaccine within 4 weeks prior to inclusion
•Pregnancy, breast feeding, women with inadequate contraception
•Malignancy
•Kidney transplantation
•Previous treatment with monoclonal antibodies

发起方

Radboud University Nijmegen Medical Center