Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Middle-to-late Stages of Chronic Kidney Disease Patients: a Multi-center Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- serum creatinine, estimated glomerular filtration rate (eGFR)
研究概览
简要总结
The purpose of this study is to determine whether febuxostat and benzbromarone could protect renal function in chinese, and which one could be better.
详细描述
Chronic kidney disease patients with hyperuricemia and glomerular filtration rate (GFR) 20-60 ml/min were treated by febuxostat or benzbromarone. Follow up the changes of serum uric acid, serum creatinine and GFR levels. Compare the effects on renal function of these two drugs.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic kidney disease patients with glomerular filtration rate (GFR,20-60ml/min) who match one of the following criteria:
- •serum uric acid > 480umol/L
排除标准
- •GFR<20ml/min or GFR >60ml/min
- •Liver dysfunction (Aspartate transaminase or/and alanine aminotransferase exceed 2 times of normal range)
- •Urinary tract obstruction
- •unstable angina, heart failure (stage III-IV, NYHA), new stroke, need diuretics for long-term treatment
- •Severe lung diseases or cancers
- •Pregnant woman or woman who prepare to be pregnant，nursing mothers
- •unable to sign informed consent form，or disagree with following-up
研究组 & 干预措施
Febuxostat
take orally,10-80mg per day, for 1 year,start with a low dose, and adjust the dose according to the level of uric acid
干预措施: Febuxostat (Drug)
Benzbromarone
take orally,12.5-100mg per day, for 1 year,start with a low dose, and adjust the dose according to the level of uric acid
干预措施: Benzbromarone (Drug)
结局指标
主要结局
serum creatinine, estimated glomerular filtration rate (eGFR)
时间窗: up to 12th months
eGFR will be estimated by CKD-EPI equation, which is most widely used recently in the world. eGFR will be calculated according to serum creatinine, age, gender and race.
次要结局
- urine protein(6th months, 12th months)
- adverse drug reaction(1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months)
研究者
Ai Peng
Professor
Shanghai 10th People's Hospital