NCT06167174招募中不适用
Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics
Chinese SLE Treatment And Research Group1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月5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
- 100
- 试验地点
- 1
- 主要终点
- Treatment response of patients
研究概览
简要总结
This is an observational study of patients with lupus nephritis aiming to find biomarkers that can predict patients' response to immunosuppressants. We planed to collect 100 lupus nephritis patients' peripheral blood,kidney tissues and urine before and after treatment (mycophenolate mofetil or cyclophosphamide, in combination with glucocorticoids). Then multi omics analysis, including single cell RNA-seq, ATAC-seq and CITE-seq, will be performed to find new biomarkers for patients' response and prognosis.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 16-60 years.
- •Fulfilling the 2012 SLICC classification for SLE.
- •Renal biopsy pathology was clearly classified as III \ IV \ V+III \ V+IV within 6 months.
- •Renal biopsy reveals active disease.
- •24-hour urinary protein was tested twice within two weeks, both of which were greater than 1g.
- •The patients have never received glucocorticoid/immunosuppressants or received standard treatment for more than 1 month without change. The standard treatment should fulfill: a. prednisone 0-20mg/day, or equivalent other glucocorticoids; b. acceptable immunosuppressants, including Tacrolimus ≤ 4mg/d, methotrexate ≤ 15mg/week, azathioprine ≤ 100mg/d and MMF ≤ 1g/d.
- •Informed consent obtained.
排除标准
- •Other concomitant connective tissue diseases or autoimmune diseases.
- •Neuropsychiatric lupus, alveolar hemorrhage, retinal lesions, pulmonary arterial hypertension, or other severe organ involvement.
- •Pregnant or lactating women.
- •Current infections that require antibiotic or antiviral treatment.
- •Other kidney diseases.
- •Platelet < 50×10^9/L.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is greater than 1.5 times the upper limit of the normal value.
- •Total bilirubin or blood lipid that is greater than 2 times the upper limit of the normal value.
- •Other conditions that not suitable for inclusion in the study, assessed by the investigators.
结局指标
主要结局
Treatment response of patients
时间窗: 24 weeks
The proportion of patients who achieve complete response, partial response or no response 24 weeks after baseline
次要结局
- Disease progression(24 weeks)
- Adverse events during the study(24 weeks)
研究者
研究点 (1)
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