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临床试验/NCT02232776
NCT02232776已完成3 期

A Prospective Study Evaluating the Efficacy and Safety of Losartan in Children With Immunoglobulin A Nephropathy

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
37
试验地点
1
主要终点
the change in urinary protein-creatinine ratio from baseline to the end of study

研究概览

简要总结

The investigators hypothesize that using Losartan would help decrease proteinuria in controlling proteinuria in children with immunoglobulin A nephropathy.

详细描述

Twenty nine patient with IgA nephropathy with proteinuria (urine protein to creatinine ratio > 0.3 mg/mg) were included in the study. All patients had received losartan treatment for 24 weeks. Changes in blood pressure, proteinuria, renal function, and biochemical parameters were prospectively evaluated before and at 4 weeks and 24 weeks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
24 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 2years or older and younger than 18 years
  • Biopsy-proven Ig A Nephropathy
  • Estimated GFR ≥ 90mL/min/m^2
  • Mean urinary protein-creatinine ratio > 0.3 g/g from three first-morning spot urine collections

排除标准

  • hypertension
  • under dialysis or organ transplanted
  • bilateral renal artery stenosis
  • primary hyperaldosteronism

研究组 & 干预措施

Losartan treatement

Experimental

All patients had received losartan treatment for 24 weeks.

干预措施: Losartan (Drug)

结局指标

主要结局

the change in urinary protein-creatinine ratio from baseline to the end of study

时间窗: 24weeks

Change in urinary protein excretion, determined as urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.

次要结局

  • the proportion of patients wifh urinary protein-creatinine ratio < 0.2 at the end of study(24 weeks)
  • the change in urinary albumin-creatinine ratio from baseline to the end of study(24 weeks)
  • the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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