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临床试验/NCT05623033
NCT05623033招募中不适用

The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection

Fifth Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2022年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
156
试验地点
1
主要终点
Dynamic changes of CD4+T cells

研究概览

简要总结

The goal of this observational study is to test whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome . The main questions it aims to answer are:

  • whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome
  • effect of different immunosuppressive therapy on the number and function of T lymphocyte subsets in patients with primary nephrotic syndrome

Participants will be divided into infection group and non-infection group according to whether they are infected

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
14 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 14 years and<75 years.
  • It meets the diagnostic criteria of primary nephrotic syndrome, i.e. a. A large amount of proteinuria (24h urine protein quantity > 3.5g/d); b. Hypoalbuminemia (liver function: albumin<30g/L); c. Edema; d. The blood lipid is elevated. Among them, item a and b are necessary conditions for diagnosis.
  • Nephrocentesis pathology indicates the pathological type of nephrotic syndrome (minimal change glomerulonephritis, membranous nephropathy, focal segmental glomerulonephritis, membranous proliferative glomerulonephritis, mesangial proliferative glomerulonephritis).
  • Glucocorticoids or corticosteroids combined with immunosuppressants should be used clinically.

排除标准

  • Secondary nephrotic syndrome, such as secondary to systemic lupus erythematosus, hepatitis B, hepatitis C, tumor, organic solvent , heavy metal poisoning, etc.
  • Patients with tumor and chronic infectious diseases, such as HIV infection, cardiac insufficiency, acute hepatitis, transaminase increase more than twice the normal value, deep vein thrombosis.
  • The subjects were pregnant and lactating women.
  • Patients with serious primary diseases such as heart, brain, liver and hematopoietic system.
  • Those who can not cooperate, such as the mentally ill.
  • It is known that it is allergic to or has contraindications to any component in glucocorticoid, FK506, MMF and CTX.
  • Serum creatinine (SCR) > 265.2 μ mol/L(3mg/dl)。

结局指标

主要结局

Dynamic changes of CD4+T cells

时间窗: 3 years after the project starts

Whether the change of CD4+T lymphocytes count can predict infections in patients with primary nephrotic syndrome

次要结局

未报告次要终点

研究者

发起方
Fifth Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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