跳至主要内容
临床试验/NCT04389827
NCT04389827已完成不适用

Global Kidney Patient Trials Network

The George Institute1 个研究点 分布在 1 个国家目标入组 5,999 人开始时间: 2020年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,999
试验地点
1
主要终点
Albuminuria

研究概览

简要总结

This is a prospective international multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney 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
2 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Documented diagnosis of primary kidney disease
  • Regular visits (6-12 monthly) with a physician at a participating site that includes the monitoring of protein in urine and kidney function
  • eGFR > 25 ml/min/1.73m2
  • ≥ 2 to ≥ 80 years of age
  • One of the following laboratory urine parameters within 12 months of screening meeting the values of:
  • Urine Albumin-to-Creatinine Ratio (UACR) > 200 mg/g OR
  • Protein-to-Creatinine Ratio (PCR) > 300 mg/g OR
  • Albumin Excretion Rate (AER) > 200 mg/day OR
  • 24 hour Albumin Excretion > 200 mg/day OR
  • 24 hour Urine Protein Excretion > 300 mg/day
  • Willing and able to sign informed consent
  • Willing to be approached about participation in interventional research studies

排除标准

  • Life-expectancy of less than 6 months
  • Currently receiving renal replacement therapy or planned to start in the next 6 months
  • Planned transplant in the next 6 months
  • Currently participating in a clinical trial involving investigational medicinal product (exception is participation in studies implemented through the GKPTN)

结局指标

主要结局

Albuminuria

时间窗: Collected Six-Monthly (minimum)

Routine results

estimated Glomerular Filtration Rate (eGFR)

时间窗: Collected Six-Monthly (minimum)

Routine results

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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