A Prospective, Randomized, Cross-over Study Evaluating the Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks
研究概览
简要总结
The investigators hypothesize that using Losartan would help decrease proteinuria in pediatric chronic kidney disease with tubular proteinuria.
详细描述
Children with tubular proteinuria (urine protein to creatinine ratio > 0.3 mg/mg) were randomly assigned in 1:1 ratio to losartan or placebo treatment for 12 weeks, then crossed over to the opposite intervention for another three months after a washout period of 2 weeks. The primary outcome is the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks. Efficacy of losartan in children with CKD with tubular proteinuria was also investigated with additional retrospective review of medical record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Age: 2years or older and younger than 18 years
- •estimated GFR ≥ 30mL/min/m^2
- •Mean urinary protein-creatinine ratio > 0.3 g/g from three first-morning spot urine collections
- •Renal hypoplasia/dysplasia, Reflux nephropathy, Polycystic kidney disease, Lowe syndrome, Dent disease, Tubulointerstitial nephritis, Nephronophthisis/Medullary cystic disease, Obstructive uropathy(including PUV, UPJ obstruction, UVJ obstruction)
排除标准
- •hypertension
- •under dialysis or organ transplanted
- •bilateral renal artery stenosis or primary hyperaldosteronism
- •pregnant or nursing
研究组 & 干预措施
Losartan
12 weeks of losartan or placebo with crossover to the other
干预措施: Losartan (Drug)
Placebo
12 weeks of losartan or placebo with crossover to the other
干预措施: Placebo (Drug)
结局指标
主要结局
the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks
时间窗: 12 weeks
Change in urinary protein excretion, determined as urinary Protein-creatinine ratio compared to baseline, after 12 weeks of treatment
次要结局
- the change in urinary albumin-creatinine ratio from baseline to the end of study(12 weeks)
- the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio(12 weeks)
- the change in urinary beta2-microglobulin-creatinine ratio from baseline to the end of study(12 weeks)
- the change in urinary NAG-creatinine ratio from baseline to the end of study(12 weeks)