Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio to Characterize and Predict Poor Prognosis Forms in IgA Nephropathy: an Exploratory Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Form of IgA nephropathy exhibited by the patient (progressive or stable)
研究概览
简要总结
This study aims to investigate the relevance of the Tfh/Tfr (Follicular helper T cells/ Follicular regulatory T cells) ratio in patients with IgA nephropathy:
- To identify a differential expression of the Tfh/Tfr ratio in patients considered stable or progressive
- To predict, at diagnosis, the clinical evolution of the disease (progressive or stable form) in the first year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •IgA nephropathy histologically proven on renal biopsy according to KDIGO criteria, with 8 permeable glomeruli (patients diagnosed from 2009 with a minimum follow-up for their nephropathy of 5 years (arm 1) or patients diagnosed during the study (arm 2))
- •Control patients: Lupus or ANCA-associated vasculitis or polycystic kidney disease (arm 3)
排除标准
- •Legal incapacity or limited legal capacity
- •Subjects with no social security coverage.
- •Pregnancy / No effective contraceptive method
结局指标
主要结局
Form of IgA nephropathy exhibited by the patient (progressive or stable)
时间窗: 12 months
Patient with a diagnosis before the start of the study: IgA nephropathy with a GFR of less than 45 ml/min/1.73 m2 and/or proteinuria \>0.5 g/day and/or hematuria (microscopic or macroscopic) will be considered progressive. Patient with diagnosis during the study: will be considered as progressive an IgA nephropathy for which the GFR will decrease compared to the inclusion (diagnosis) of more than 5 ml/min/1.73 m2 and/or with a proteinuria \>0.5 g/day and/or with a microscopic hematuria on at least one of the samples carried out in a period of one year after the diagnosis.
次要结局
未报告次要终点