Individualized Treatment of Hyperphosphatemia Based on Phosphate Balance in Maintenance Hemodialysis Patients: a Multicenter, Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Achievement rate of serum phosphorus
研究概览
简要总结
The research is designed as a prospective, randomized, controlled clinical trial without blinding. A total of 116 participants with hyperphosphatemia will be enrolled from three hemodialysis center (56 from Huashan Hospital, 30 from Huadong Hospital and 30 from Tongji Hospital). All participants will be randomly divided into control group and intervention group in a ratio of 1:1. Phosphorus balance status is evaluated in participants of the intervention group by the phosphorus balance calculator. Then, these participants will be given individualized phosphate-binders, dietary and dialysis intervention according to the results of phosphorus balance evaluation. Participants in the control group will not receive the phosphorus balance status evaluation but receive phosphate-binder treatment according to the KDIGO Guidelines. Dietary phosphorus intake, dialysate calcium concentration and dose of active vitamin D, phosphorus-binders of all participants will be recorded during the whole research program. After two-week treatment, the phosphorus balance of participants in intervention group will be evaluated again and the therapeutic strategies then will be adjusted. At the same time, the therapeutic strategies of participants in the control group will be adjusted according to the serum phosphorus concentration. All participants will be followed up for two weeks again and receive blood test and related examinations at the end of study. The results of final examinations will be analyzed to evaluate the efficacy of individualized treatment of hyperphosphatemia.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject within 18-85 years old, male or female.
- •Subject receiving maintenance hemodialysis 3 times weekly at least 3 months with autologous arteriovenous fistula.
- •Subject with hyperphosphatemia as defined by serum phosphorus concentration >1.45mmol/L.
- •Subject in a good general condition with a stable dietary habit.
- •Subject has insight of the disease and treatment himself/herself and haves ability to communicate with others.
- •Subject has provided informed consent.
排除标准
- •Subject has residual renal function.
- •Subject with severe infection, anemia (Hb<60g/L) or hypoproteinemia (Alb<30g/L).
- •Subject has cancer or cachexia.
- •Subject with a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 3 months.
- •Subject with severe hematopoietic system disease, such as aplastic anemia, thalassemia and thrombocytopenic purpura.
- •Subject with severe gastrointestinal system disease such as dysphagia, hypohepatia, Active gastrointestinal bleeding, ileus, enterobrosis, or received subtotal gastrectomy.
- •Subject with disease which affects serum phosphorus concentration such as hypoparathyroidism (iPTH<11pg/ml), severe hyperparathyroidism (iPTH>600pg/ml) and type 2 vitamin D dependence rickets.
- •Subject is pregnant.
- •Subject is currently enrolled in or has completed any other investigational device or drug study<30 days prior to screening, or is receiving other investigational agents.
- •Subject has inadequate hemodialysis with a recent spKt/V<1.
- •Subject has a poor nutritional status with a recent (nPNA<1.0g/kg/d) .
- •Subject is not a good participant for the research in the opinion of the investigator.
研究组 & 干预措施
Control group
干预措施: Phosphate-binder intervention (Drug)
Intervention group
干预措施: Phosphate-binder intervention (Drug)
Intervention group
干预措施: Phosphorus-restricted dietary intervention (Dietary Supplement)
结局指标
主要结局
Achievement rate of serum phosphorus
时间窗: Four weeks after treatment
Serum phosphorus concentration
时间窗: Four weeks after treatment
次要结局
- Serum calcium concentration(Four weeks after treatment)
- Serum iPTH concentration(Four weeks after treatment)
- Serum albumin concentration(Four weeks after treatment)
研究者
Chen Jing
Professor
Huashan Hospital