Validation of the Assay of Circulating Antibodies Against Glomerular Neo-autoantigens as a Surrogate Biomarker of the Development of Lupus Nephritis
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Change from baseline in Proteinuria at 12, 24 and 36 months
研究概览
简要总结
The purpose of this study is to clarify the mechanisms involved in the formation and glomerular deposition of immune complexes in lupus nephritis.
The determination of an antibody pattern specific for systemic lupus erythematosus and lupus nephritis may also have a role in predicting disease progression in patients with systemic lupus erythematosus without renal impairment. As for the patients enrolled in the study, the determination of their antibody patterns may contribute to a more targeted and personalized treatment, allowing a prediction of disease progression and the introduction of early targeted treatments, in order to block the onset and/or progression of renal damage.
详细描述
Prospective multicenter study on the validity of levels of circulating antibodies to glomerular neo-autoantigens (alpha-enolase and annexin AI) and implantable antigens (anti-DNA, histone, istone3, istone4, C1q) as a surrogate biomarker for the diagnosis of lupus nephritis.
The study will involve the collection of serum from patients with lupus nephritis at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the titration of circulating autoantibodies.
As a control the investigators will use the sera of patients with systemic lupus erythematosus without nephropathy, collected at the same time intervals.
The investigators will also assess the antibody positivity in groups of patients with rheumatologic disease similar to lupus (rheumatoid arthritis) and in patients with autoimmune nephropathy without extrarenal clinical signs.
Regarding patients with systemic lupus erythematosus the investigators will collect sera of both incident and prevalent patients in order to monitor changes in antibody levels in conjunction with the development of renal disease.
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
- 4 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 4 and 65 years
- •Diagnosis of lupus nephritis-systemic lupus erythematosus (systemic lupus erythematosus, rheumatoid arthritis and membranous nephropathy for controls)
- •Informed consent
排除标准
- •Severe infections in place
- •Malignancies of any current or history
- •Chronic hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) positive
- •Breast-feeding or pregnant
- •Known hypersensitivity to drugs
结局指标
主要结局
Change from baseline in Proteinuria at 12, 24 and 36 months
时间窗: 12, 24, 36 months
proteinuria measured on a 24-hour urine collection.
次要结局
- Renal function(36 months)
研究者
Gian Marco Ghiggeri MD, PhD
MD
Istituto Giannina Gaslini