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临床试验/NCT02954419
NCT02954419招募中不适用

IgA Nephropathy Biomarkers Evaluation Study (INTEREST)

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
A doubling of serum creatinine level from baseline

研究概览

简要总结

This prospective cohort study is designed to examine the association between blood and urine biomarkers (including genetic variants) and long-term kidney disease progression among 2000 Chinese IgA nephropathy patients with relatively normal kidney function (eGFR≥60 ml/min/1.73 m2).

详细描述

Glomerulonephritis is the leading cause of end-stage renal disease (ESRD) in China, where IgA nephropathy (IgAN) is the most common primary glomerulonephritis among individuals undergoing renal biopsy. The outcomes of IgAN vary highly among individuals; some have the stable renal function for lifetime and some quickly progress to ESRD. No biomarker is widely applied to predict the outcomes in IgAN yet. Previous GWAS studies including ours have identified some susceptibility loci associated with the development and clinical features of IgAN. In addition, a few cohort studies have revealed several genetic loci related to the progression of IgAN. But, all of the reported GWAS studies were based on a case-control design, which may not provide the information about the effect of genetic variants on the progression of disease. Previous cohort studies which focused on certain specific candidate genes cannot unbiasedly explore the progression related susceptibility loci. Furthermore, there is no study that integrates the information from whole genomic loci and serum and urine biomarkers to predict the long-term progression in IgAN. Therefore, we design a relative large prospective cohort study to examine the association between blood and urine biomarkers (including whole genomic loci) and long-term kidney disease progression among 2000 Chinese IgAN patients with relatively normal kidney function (eGFR≥60 ml/min/1.73 m2).

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

入选标准

  • Male or female individuals aged 14 years or older
  • Patients with biopsy-proven primary IgA nephropathy
  • A renal biopsy available for reviewing must include 10 or more glomeruli.
  • The first renal biopsy was performed within 3 years.
  • eGFR ≥ 60 ml/min/1.73 m2 (MDRD formula);
  • Individuals or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF).

排除标准

  • Relatives were diagnosed with biopsy-proven primary IgA nephropathy;
  • Individuals had secondary IgA nephropathy due to diseases such as diabetes, chronic liver disease and systemic lupus erythematosus.

研究组 & 干预措施

IgA nephropathy group

Eligible biopsy-proven primary IgA nephropathy patients.

干预措施: No intervention (Other)

结局指标

主要结局

A doubling of serum creatinine level from baseline

时间窗: 120 months

Death

时间窗: 120 months

Progression to end stage renal disease (eGFR<15ml/min/1.73 m2, dialysis or transplantation)

时间窗: 120 months

次要结局

  • Remission of proteinuria (complete or partial)(120 months)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xue Qing Yu

Professor

Sun Yat-sen University

研究点 (1)

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