Efficacy and Safety of Cholestyramine in the Management of Hyperphosphatemia in Adult Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- serum phosphate level
研究概览
简要总结
After the end of trial, we will examine if cholestyramine has a significant efficacy on reducing serum phosphate level in adult hemodialysis patients.
Time of the trial will be two months (8 weeks trial period)
Baseline characteristics: The following data will be collected from all patients at baseline
- Age, sex, weight, duration of ESRD and hemodialysis comorbidities.
- Dialysis duration, serum phosphate level, serum calcium level, iPTH, BUN, Cr (mg/d L), Albumin (mg/d L), Hb (g m%), renal function test, liver function test, blood glucose level, TG, total cholesterol level, LDL-C, HDL.C.
After the end of trial, we will examine if cholestyramine has a significant efficacy on reducing serum phosphate level in adult hemodialysis patients.
详细描述
Chronic kidney disease-mineral and bone disorder (CKD-MBD) is characterized by progressive loss of renal function as well as dysregulation of mineral and bone metabolism, leading frequently to hyperphosphatemia.
Multiple studies have consistently shown that hyperphosphatemia is associated with cardiovascular events and increased morbidity and mortality in end-stage renal disease (ESRD) patients.
Importantly, use of phosphate binding agents and reduction of serum phosphate concentration are associated with a lower risk of mortality.
The most widely used phosphate binders are calcium-based, although they are frequently associated with hypercalcemia and vascular calcification.
Colestilan is a non-metallic phosphate binder that acts as an anion-exchange resin. Colestilan itself is not absorbed after oral administration, and it is able to bind dietary phosphate within the gastrointestinal tract and thus prevent absorption of the mineral.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients aged ≥18 years with CKD stage (4&5)
- •Serum phosphate level ≥ 5.5 mg/dL
- •Serum LDL-C level ≥1.82 mmol/L (70 mg/dL)
- •Hemodialysis frequency 3 times per week or more.
- •Hemodialysis in the last 3 months or longer.
排除标准
- •Patients are excluded if they have a history of dysphagia, or swallowing disorder.
- •2-patients require warfarin or digoxin treatment. 3- Patients have a history of alcohol or substance abuse 4- Patients receiving calcimimetics. 5- Pregnant patients. 6- Patients have Triglyceride level above 300 (mg/dl)
研究组 & 干预措施
Test group
Group 1:
(cholestyramine 12 gram), 40 patients will take a dose of cholestyramine 4-gram sachets three times daily within meals with (Calcimate).
Dosage: one sachet on 150 ml water three times daily duration : 8 weeks
干预措施: Cholestyramine Resin 4000 MG [Questran] (Drug)
Test group
Group 1:
(cholestyramine 12 gram), 40 patients will take a dose of cholestyramine 4-gram sachets three times daily within meals with (Calcimate).
Dosage: one sachet on 150 ml water three times daily duration : 8 weeks
干预措施: Calcium Carbonate 500 MG Oral Tablet (Drug)
Control group
Group 2: Control group, 40 patients will take only (Calcimate).
干预措施: Calcium Carbonate 500 MG Oral Tablet (Drug)
结局指标
主要结局
serum phosphate level
时间窗: 8 weeks trial period
measuring serum phosphate level at baseline and after 8 weeks trial period to evaluate serum phosphate reduction by cholestyramine
serum calcium level
时间窗: 8 weeks trial period
measuring serum calcium level at baseline and after 8 weeks trial period to evaluate serum calcium reduction by cholestyramine
iPTH
时间窗: 8 weeks trial period
measuring iPTH level at baseline and after 8 weeks trial period to evaluate iPTH reduction by cholestyramine
次要结局
- Lipid Profile ( triglyceride level , LDL ,HDL ,Total cholesterol )(8 weeks trial period)
研究者
Ahmed Essam Aly
Demonstrator at clinical pharmacy department , Sinai university
Ain Shams University