Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Glucocorticoids Plus Cytoxan
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Remission
研究概览
简要总结
The goal of this observational study is to explore the factors that can predict the prognosis difference in patients with idiopathic membranous nephropathy (IMN) under the treatment of glucocorticoid + cytoxan. The main questions it aims to answer are:
- to explore the factors that can predict the prognosis difference in patients with IMN under the treatment of glucocorticoid + cytoxan
- to establish a clinical prediction model and verify it to provide a reference for the early Participants will receive standard glucocorticoid + cytoxan treatment and will then be divided into remission and non remission groups based on the treatment effect after the standard treatment cycle. Blood, urine, and fecal samples were collected from patients to explore possible factors influencing treatment efficacy.
Researchers will compare [remission group and non-remission group] to see if the gut microbiota and its metabolites are factors that influence the efficacy of treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years, the patient was diagnosed as idiopathic membranous nephropathy or anti phospholipase A2 receptor (PLA2R) antibody positive by renal puncture biopsy, and the clinical data were complete;
- •According to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines in 2020, it conforms to the medium and high risks in the risk level of progression of renal function loss.
- •In general, they are in good condition, have a good understanding of their own conditions and physical conditions, have self-awareness, and can communicate well with others;
- •Volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form.
排除标准
- •There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or toxins;
- •At the same time, immunoglobulin A nephropathy (IgAN), interstitial nephritis, acute nephritis and other renal pathological types were combined;
- •The medication was not standardized during the treatment process, accompanied by serious infection, acute renal injury and other complications, and serious cardiovascular, cerebrovascular, digestive and blood system diseases;
- •During follow-up, the patient cannot actively cooperate or accurately understand and express.
研究组 & 干预措施
Remission
干预措施: glucocorticoid + cytoxan (Drug)
Non-remission
干预措施: glucocorticoid + cytoxan (Drug)
结局指标
主要结局
Remission
时间窗: 6 months
1. None-Remission of the State of MN: 1) 24-hour urin protein (24-h UP)\>3.5 g, or 24-h UP\<50% lower than the baseline, or serum creatinine increased by 50% compared with the baseline; 2) Renal function progress: Compared with the initial examination, estimated glomerular filtration rate (eGFR) progress is greater than or equal to 30%; 3) End stage renal disease: eGFR\<15ml/min, or renal replacement therapy. 2. Partial Remission of the State of MN: 24-h UP is 0.5-3.5 g, and 24-h UP is more than 50% lower than the baseline, serum creatinine is normal, and plasma albumin is ≥ 30 g. 3. Complete Remission of the State of MN: 24-h UP\<0.5g, serum creatinine normal, plasma albumin ≥ 35g.
次要结局
未报告次要终点
研究者
Zunsong Wang
Principal Investigator
Qianfoshan Hospital