Optimization of a Decision Formula for Optimal Timing of Immunosuppressive Therapy Initiation in Primary Membranous Nephropathy: A Multicenter Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Reasonably add immunosuppressive therapy
研究概览
简要总结
The goal of this observational study is to optimize the evaluation formula for the timing of initiating immunosuppressive therapy in primary membranous nephropathy in patients with primary membranous nephropathy. The main question it aims to answer is:When should immunosuppressive therapy be initiated?This study is a retrospective one. Participants will not receive any treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It meets one of the diagnostic criteria for PMN as stipulated in the KDIGO 2021 Clinical Practice Guidelines for the Management of Glomerular Diseases: patients with a clear diagnosis of PMN based on renal biopsy pathology or presenting with nephrotic syndrome and positive anti-PLA2R antibody detection (>14RU/mL), and excluding secondary factors such as tumors, infections, drugs, and systemic autoimmune diseases.
排除标准
- •(1) Patients who have received treatment with immunosuppressive medications other than oral prednisolone.
- •(2) The time interval between the renal biopsy and the baseline measurement is longer than 3 years.
- •(3) Initiate the use of immunosuppressive agents within 1 week after the diagnosis of PMN.
- •(4) Participate in the immunosuppressive treatment trial during the follow-up period and be in the intervention group.
结局指标
主要结局
Reasonably add immunosuppressive therapy
时间窗: From enrollment to the reasonable addition of immunosuppressive agent treatme，no less than one weeknt
Reasonably add immunosuppressive therapy, that is, refer to the risk stratification of PMN in the "KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases". Immunosuppressive therapy can be initiated for patients with moderate or higher risk; or for those whom the treating doctor deems to require immunosuppressive therapy due to severe and incurable nephrotic syndrome and its serious complications. Meeting either of the two conditions is sufficient.
次要结局
未报告次要终点
研究者
Yipeng Liu
Clinical Professor
Qianfoshan Hospital