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临床试验/NCT04756492
NCT04756492Unknown不适用

Prognostic Factors for Treatment Responses in Patients With Active Lupus Nephritis at Sohag University Hospital

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月15日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
complete renal response

研究概览

简要总结

Systemic lupus erythematosus (SLE) is an autoimmune disease which may give rise to multiple organ involvement because of immune complex deposits. Lupus nephritis (LN) is one of the severe manifestations of systemic lupus erythematous (SLE) and a common cause for end-stage renal disease, significantly affecting the survival of SLE patients Immunosuppressive treatment is the major therapy for active LN. Generally, at least six months are needed to assess treatment responses Failure to respond to immunosuppressive therapy can lead to a worsening of renal function

详细描述

This study will be prospectively analyzing the clinical data of LN patients who received standard immunosuppressive therapy and were regularly followed up at our center for more than six months. These patients will not change treatment regimen during the six months.

As remission is an independent predictor of good long term prognosis in lupus nephritis. We aim to examine the predictors of sustained complete renal remission in patients with lupus nephritis at Sohag University Hospital and to analyze data of lupus nephritis patients to find parameters that can predict remission and improve outcome of our cases

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
14 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • o Patients diagnosed with LN at Sohag University Hospital
  • Patients in regular follow-up for more than six months after immunosuppressive therapy
  • Baseline urinary protein/creatinine ratio (UPCR) more than 1 g/g
  • Baseline C3 less than 55 mg/ dl
  • No change in immunosuppressive therapy within six months

排除标准

  • o Patients with incomplete pathological data and the number of glomeruli being <10 per biopsy specimen
  • Age <14 years old End-stage renal disease (ESRD) status on admission (sustained estimated glomerular filtration rate (eGFR) <15 ml/min per 1.73m2)
  • Patients with advanced comorbid conditions like advanced liver cirrhosis or heart failure or malignancy

结局指标

主要结局

complete renal response

时间窗: 6 months

Alb _35 g/l, UPCR\<0.3 g/g, a normal range of sCr or at a level increasing no more than 15% from baseline and without lupus flares.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mahmoud Helmy

assistant lecture

Sohag University

研究点 (1)

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