Study of the Link Between Complement Activation and IgA Nephropathy Severity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Incidence of a severe form of IgA nephropathy
研究概览
简要总结
ICONE study (IgA Complement and NEphropathy is a prospective monocentric observational study.
The main objective is to evaluate the relevance of complement activation as a biomarker of disease severity and progression in patients with a biopsy proven IgAN.
详细描述
IgA nephropathy (IgAN) is a common cause of glomerulonephritis and a major cause of end stage renal disease in up to 20-40% of patients. However, its prognosis still cannot be accurately predicted due to the high heterogenicity of clinical presentations and courses. Complement dysregulation is a main driver of glomerular damages in many glomerulonephritis. Given the growing body of evidence of complement lectin/alternative pathways activation in IgAN pathogenesis, the investigators propose the evaluation of a combination of biomarkers of infra-clinical complement activation to stratify the risk of disease's progression. This study aims to identify subsets of patients in whom complement activation plays a critical role in disease progression. This is of particular interest in the aera of emergence of complement-targeting therapies in IgAN
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, male or female, with a biopsy proven IgA nephropathy.
- •Primitive and secondary forms can be included
- •Regardless of the date of diagnosis and the level of kidney function
- •With or without past of kidney transplantation
- •Followed in the Nephrology Department, Strasbourg University Hospital
- •Signed informed consent
排除标准
- •Active or recent infectious or inflammatory syndrome (<2 months), recent vaccination (<2 months), ongoing acute humoral rejection treatment, treatment with plasma exchanges (<2 months), current treatment with complement inhibitors
- •Impossibility of giving informed information (emergency situation, difficulties in understanding, etc.)
- •Subject under safeguard of justice, guardianship or curatorship
结局指标
主要结局
Incidence of a severe form of IgA nephropathy
时间窗: 1 year after inclusion
Occurrence of a severe form of IgA nephropathy, with at least one of the following severity criteria: i) a rapid decline in estimated glomerular filtration rate the presence of malignant hypertension or thrombotic microangiopathy features, iv) histological endo and/or extra capillary proliferation (E1 and/or C1 according to Oxford 2016 MEST-C score).
Incidence of a severe form of IgA nephropathy
时间窗: At inclusion
Occurrence of a severe form of IgA nephropathy, with at least one of the following severity criteria: i) a rapid decline in estimated glomerular filtration rate the incidence of end stage kidney disease, iii) the presence of malignant hypertension or thrombotic microangiopathy features, iv) histological endo and/or extra capillary proliferation (E1 and/or C1 according to Oxford 2016 MEST-C score). Infra-clinical complement activation is defined as a sC5b-9 \> 300ng/mL in plasma or a positive ex vivo complement activation functional test on endothelial cells.
次要结局
未报告次要终点