Exploratory pathophysiological study in five patients suffering from new-onset lupus nephritis and treated with rituximab as first-line treatment - NL_RTX_FIRST

Cliniques Universitaires Saint-lus, Université catholique de Louvain0 个研究点目标入组 5 人开始时间: 2017年4月21日最近更新: 2020年9月7日

试验速览

暂无简介。

•Age = 15y (except if local ethics committee imposes = 18y) and = 65 y
•systemic lupus erythematosus, according to (ACR/SLICC criteria
•early untreated Lupus nephritis class III or IV (ISN/RPS 2003), associated or not to class V
•uP/C ratio =1 mg/mg measured in a 24-h urine collection
•No immunosuppressive therapy (never)
•No targeted biological therapy never)
•No renal failure (eGFR < 60 mL/min)
•No Biological and clinical nephrotic syndrome
•Contraception (any type)
•Signed informed consent (drafted according to local practice and approuved by the local ethics committee)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Breast-feeding
•Renal failure (eGFR < 60 mL/min)
•Biological and clinical nephrotic syndrome
•HIV, HCV, HBV infections
•Active tuberculosis
•History of malignancy (except non-melanoma skin and cervical intraepithelial cervical cancer)
•Previous targeted biological therapy
•Intercurrent disease interfering with treatment and/or clinical evaluation

发起方

Cliniques Universitaires Saint-lus, Université catholique de Louvain