The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Urinary protein remission rate
研究概览
简要总结
This prospective study aims to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.
详细描述
Autoimmunity may play an important role in IgA nephropathy, and previous studies have shown that immune repertoire sequencing (IR-Seq) may help elucidate the dynamic changes of immune repertoire (IR) in autoimmune disease states. To further explore the potential application value of this technology, we will conduct a series of prospective studies to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IgA nephropathy:
- •Age: 18-80 years.
- •Patients diagnosed with primary IgA nephropathy by renal biopsy.
- •Estimated glomerular filtration rate (using the 2009 CKD-EPI formula) ≥30ml/min/1.73/m^
- •Obtain informed consent from patients.
- •Healthy Control: Gender, age and ethnicity matched health volunteers.
- •IgAN patients were further divided into 4 groups, as defined below:
- •Long-term stable patients:
- •Follow-up for at least 15 years and meet at least one of the following:
- •Annual eGFR loss rate <3ml/min/1.73m^
- •eGFR>90ml/min/1.73m^
- •Non-progressive IgAN patients:
- •Meet at least one of the following:
- •eGFR decrease of more than 50% from baseline (in the absence of other possible causes of kidney damage).
- •Annual eGFR loss rate >5ml/min/1.73m^
- •Progress to ESRD. 3) IgAN patients at low risk of disease progression: Proteinuria ≤ 1g/24h after 3 months of optimized supportive care. 4) IgAN patients at high risk of disease progression: Proteinuria > 1g/24h despite 3 months of optimized supportive care.
排除标准
- •Kidney biopsy shows crescentic IgAN or MCD-IgAN.;
- •Patients with secondary IgAN;
- •During pregnancy or lactation;
- •After kidney transplantation;
- •More than one serious acute infection in the psat 12 months;
- •Chronic infection;
- •Use of glucocorticosteroids and other immunosuppressive drugs within the last 6 months;
- •Incomplete medical history or clinical data.
研究组 & 干预措施
IgAN patients at low risk of disease progression
n = 30, incipient disease
干预措施: Intervention for incipient patients at low risk of disease progression (Drug)
IgAN patients at high risk of disease progression
n = 60, incipient disease
干预措施: Intervention for patients at high risk of disease progression (Drug)
结局指标
主要结局
Urinary protein remission rate
时间窗: 24 weeks
Including complete and partial remission rate of urinary protein. Complete remission criteria: post-treatment urine protein \<0.3 g/24h; partial remission criteria: post-treatment urine protein \<50% of the maximum value.
次要结局
- eGFR (estimated using the 2009 CKD-EPI formula)(24 weeks)
- 24-hour urine protein level(24 weeks)
- Serum albumin level(24 weeks)