Personalized Medicine for Membranous Nephropathy PMMN - PMM

CHU de Nice0 个研究点目标入组 64 人开始时间: 2018年8月14日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•-Age 18 years or more
•-Anti-PLA2R1 activity detected by ELISA or Euroimmune IFA
•-Nephrotic syndrome defined by proteinuria > 3.5 g/24h (or UPCR > 3.5 g/g) and serum albumin < 30 g/L at diagnosis
•-eGFR (CKD-EPI) > 30 ml/min/1,73 m2 at diagnosis
•-Symptomatic treatment according to KDIGO guidelines: maximal tolerated dose of NIAT (angiotensin-converting enzyme inhibitor and/or angiotensin 2 receptor blockers, diuretics and statins)
•-Medical insurance
•-Signed informed consent
•-Having understood and accepted the need for long-term medical follow-up
•-Woman of child-bearing age must be using an effective method of contraception
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•-Secondary MN: MN related to cancer, infectious, systemic lupus erythematosis, drug
•-Anti-PLA2R1 antibodies not confirmed by central analysis (in this case the patient will be replaced)
•-Pregnancy or breastfeeding
•-Immunosuppressive treatment in the 3 last months
•-Cancer under treatment
•-Patient with complicated nephrotic syndrome that would require early immunosuppressive treatment (thrombosis, acute renal failure…)
•-Patients with active, severe infections or active hepatitis B
•-Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients
•-Patients in a severely immunocompromised state
•-Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
•-Patients unable to give an informed consent

发起方