The Effects of Low Protein Diet Supplemented With Ketoanalogues on Preservation of Residual Kidney Function Among Patients Undergoing Incremental Dialysis
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 主要终点
- residual renal function
研究概览
简要总结
The investigators hypothesized that combination of incremental hemodialysis and ketoanologues will better preserve residual kidney function and maintenance of nutritional status among the incident ESRD patients during the early initiation of chronic dialysis. This hypothesis has been a new concept of chronic hemodialysis initiation for End stage renal disease (ESRD) patients
详细描述
The investigators plan to conduct the first randomized Phase IIA clinical trial to investigate the efficacy of incremental hemodialysis and moderately low protein diet combined with ketoanologues supplementation on preservation of residual kidney function, inflammatory status and nutritional parameters among incident chronic dialysis patients
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at screening
- •Stable CKD stage 5 not yet on dialysis with residual kidney function 5-10 ml/min/1.73m2 by CKD-EPI equation
- •Urine output ≥ 800 ml/day
- •Willing to participate in the study and can provide inform consent
排除标准
- •Rapid glomerular filtration rate (GFR) progression defined as a decline of eGFR >10 ml/min/1.73m2 by CKD-EPI equation in the prior 6 months before enrollment
- •Presence of wasting diseases, cancer cachexia, tuberculosis, AIDS wasting syndrome
- •Other active infection/inflammation determined by CRP >10 mg/L
- •Severe gastrointestinal problem: persistent nausea/vomiting, dysphagia, chronic diarrhea, severe malabsorption
- •Conditions at baseline requiring withdrawal from the study including severe protein energy wasting by SGA and MIS score, prior kidney transplantation with immunosuppressive agents or other serious medical conditions.
- •Pregnancy
- •Uncontrolled hypercalcemia (persistent serum Ca ≥10.5 mg/dl)
- •BMI ≥ 35 kg/m2
- •Hypersensitivity to the active substances or to any of the excipients of Ketosteril
- •Disturbed amino acid metabolism
研究组 & 干预措施
Ketosteril
Incremental hemodialysis program, starting from once weekly hemodialysis/hemodialysis filtration(HDF) plus low protein diet (0.6 g/kg/day) and ketoanologues 0.12g/kg/day supplementation on non-dialysis days and regular protein diet (1.0-1.2 g/kg/day) on dialysis day
干预措施: Ketosteril (Drug)
结局指标
主要结局
residual renal function
时间窗: 12 months
To demonstrate superiority effect of incremental hemodialysis (HD) protocol (initiate with once-weekly hemodialysis) plus ketoanalogues-supplemented low-protein diet during non-dialysis days over the standard HD protocol (initiate with twice weekly hemodialysis) on preservation of residual renal function (renal urea clearance) at 12 months.
次要结局
- structural protein(12 months)
- muscle function(12 months)
- visceral protein(12 months)
研究者
Kearkiat Praditpornsilpa
Professor of Medicine
Chulalongkorn University