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临床试验/NCT06520670
NCT06520670尚未招募不适用

Urinary galectin_3 Binding Protein as a Novel Biomarker in Lupus Nephritis and Indicator for Disease Activity

Assiut University0 个研究点目标入组 70 人开始时间: 2024年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
Level of galectin_3 binding protein in urine samples .

研究概览

简要总结

Estimation of urinary Galectin-3 binding protein (u-Gal-3BP) in patients with systemic lupus erythematosus with and without lupus nephritis and in glomerulonephritis for other kidney diseases, Find the relation of urinary Galectin-3 binding protein (u-Gal-3BP) levels with lupus nephritis, and Correlate urinary Galectin-3 binding protein (u-Gal-3BP) levels with SLE disease activity

详细描述

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with multisystem involvement. The condition has several phenotypes, with varying clinical presentations from mild mucocutaneous manifestations to multiorgan and severe central nervous system involvement. Several immunopathogenic pathways play a role in the development of SLE. Hargraves described the lupus erythematosus (LE cell) in 1948. Several pathogenic autoantibodies have since been identified. Despite recent advances in technology and understanding of the pathological basis and risk factors for SLE, the exact pathogenesis is still not well known. Diagnosis of SLE can be challenging, and while several classification criteria have been posed, their utility in the clinical setting is still a matter of debate. Management of SLE is dictated by organ system involvement. Despite several agents shown to be efficacious in treating SLE, the disease still poses significant morbidity and mortality risk in patients.

Lupus nephritis (LN) is a highly prevalent and serious clinical manifestation among patients with systemic lupus erythematosus (SLE). It affects up to 60% of patients, depending on the examined cohort. Although SLE management has improved, LN still represents a difficult to treat manifestation, with renal flares occurring in about half of the patients and development of end stage renal disease (ESRD) in 5%20% of patients.

Lupus nephritis directly contributes to SLE-related mortality, both in the early and later disease phase.

Lupus nephritis diagnosis relies on kidney biopsy, which is instrumental for histological characterization, and treatment decisions. However, the biopsy procedure is invasive, often associated with discomfort for the patient, and sometimes with bleeding complications. Although repeated biopsies have been shown to be of value, their utility still remains controversial for verifying treatment effects, monitoring disease and predicting outcomes in clinical practice.

In this context, it is highly desirable to identify new non-invasive biomarkers that may reflect the type of kidney involvement, reflect the degree of histological activity and damage, predict LN flares and be useful for assessing treatment response. In this respect, urinary biomarkers are of high relevance since they can serve as liquid biopsy and reveal pathogenic events taking place in the kidney.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any age above 18 years.
  • Patient with Lupus nephritis diagnosed by biopsy.
  • Patient with SLE without nephritis.
  • Patient with nephritis of other reasons; acute proliferative glomerulonephritis (postinfectious and infection associated), crescentic glomerulonephritis, else.

排除标准

  • Pregnant.
  • Patient who refused to be part of the study.
  • Patients with estimated Glomerular Filtration Rate less than 15ml/min

结局指标

主要结局

Level of galectin_3 binding protein in urine samples .

时间窗: baseline

Level of galectin_3binding protein in urine samples by pg/mmol using ELISA in patient with lupus nephritis.

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

Azza Mahmoud Hussien Ali

Principal investigator

Assiut University

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