Randomized, Open-Label, Prospective Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Residual Renal Function (RRF) in Peritoneal Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume
研究概览
简要总结
This randomized, open-label, prospective study will evaluate the renal effective effect of compound α-Keto Acid plus low protein diet in PD Patients.
详细描述
Residual renal function (RRF) is associated with cardiovascular complication, nutritional status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients. Therefore, RRF is an important determinant of mortality and morbidity in PD patients.
Previous studies have suggested that dietary protein restriction supplemented with compound keto/amino acids may slow the loss of RRF in chronic kidney disease patients. However, there is very few reports to address the effect of compound keto/amino acid supplementation in RRF in PD patients.
The aim of this study is to evaluate the protective effect of compound α-Keto Acid plus low protein diet in RRF in PD Patients.This is a randomized, open-label, prospective study. 100 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. α-Keto Acid group will use compound α-Keto Acid plus low protein diet, while control group will use normal protein diet.Compound α-Keto Acid dosage is 0.1/kg/d daily. The effect of compound α-Keto Acid plus low protein diet in RRF will be evaluated after 1 year treatment.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on PD at least one month prior to study entry.
- •Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old.
- •Residual GFR ≥3 ml/min/1.73m
- •Residual urine volume ≥ 500 ml/24h.
- •No history of taking α-Keto Acid within 2 weeks.
- •Subjects who agree to participate in the study and sign the informed consent.
排除标准
- •History of peritonitis or other infection within one month.
- •History of taking drug which may affect amino acid metabolism within one month.
- •Incapable of following study requirements to control diet.
- •With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.
- •Participation in another clinic trial within one month prior to screening.
结局指标
主要结局
The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume
时间窗: Every 3 months
次要结局
- Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects.(Every 3 months)
研究者
Xue Qing Yu
Professor
Sun Yat-sen University