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临床试验/NCT03806998
NCT03806998已完成3 期

Effects of a Ketoacid Supplementation on Urinary Urea Nitrogen Excretion in Patients With Stage III to IV Renal Failure

University of Chile1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
147
试验地点
1
主要终点
Estimated glomerular filtration rate

研究概览

简要总结

The aim of the study is to demonstrate that a ketoacid supplement in patients with stage III to IV chronic renal failure, reduces the excretion of urinary urea nitrogen

详细描述

Patients with an estimated glomerular filtration rate of less than 25 ml/kg/min, not on renal substitution therapy, without important concomitant diseases and aged between 40 and 70 years, will be invited to participate in the study. They will be randomly assigned to a group that will receive receive a supplement of ketoacids (Ketosteril) 1 tablet containing 630 mg of ketoacids every 5 kg of body weight and a diet containing 25 to 35 kcal/kg and 0.3 g/protein per day or to a group receiving placebo and a diet containing 25 to 35 kcal/kg and 0.6 g/protein per day. The intervention will last 16 weeks. At baseline and the end of the intervention a blood sample will be obtained to measure creatinine, urea nitrogen and cystatin C. Also a spot urine sample will be obtained to measure urea nitrogen and creatinine excretion. The compliance with the dietary prescription and the ketoacid or placebo supplement will be assessed every 2 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

There will be no masking of the treatment arm for researchers

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Estimated glomerular filtration rate of less tan 25/ml/min/1.73m2
  • Not on renal substitution therapy
  • Absence of severe life threatening concomitant diseases

排除标准

  • Malignant or renovascular hypertension
  • Use of systemic steroids or immunosuppressant drugs
  • Alcohol or illicit drug abuse
  • A body mass index of less tan 18 kg/m2

结局指标

主要结局

Estimated glomerular filtration rate

时间窗: 16 weeks

glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C

Urinary urea nitrogen excretion

时间窗: 16 weeks

Measurement of urea nitrogen i na spot urine sample

次要结局

未报告次要终点

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eduardo Lorca

Chief Cardiovascular Program

University of Chile

研究点 (1)

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