Comparison of Nicotinamide and Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 176
- 试验地点
- 13
- 主要终点
- The comparison between nicotinamide and Sevelamer was primarily to demonstrate the noninferiority of nicotinamide in terms of control of the phosphatemia observed during the 4th, 5th and 6th months before to introduce Cinacalcet ®.
研究概览
简要总结
The comparison between nicotinamide and sevelamer aims to demonstrate, in chronic hemodialysed patients, the non-inferiority of nicotinamide in terms of control of the phosphatemia. Secondary objectives is to compare the two treatments in terms of efficiency in other biological parameters, vascular calcification and bone mass loss and on the clinical and biological tolerance and finally to explore the roles of metabolites of nicotinamide.
详细描述
This is a multicenter randomized open study with 2 treatment arms (nicotinamide / Sevelamer).
Laboratories who will dose biochemical parameters and PTH, ignore which treatment is received by patients.
The team which will measure bone density and the radiologist or rheumatologist who will appreciate centrally calcification and deformity of the vertebrae, ignore which treatment is received by patients.
Therefore it's a Randomized Prospective Blinded Outcome Endpoint.
Pre-recruitment period (3 to 6 months) with basic medication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Women or men over 18 years
- •Chronic hemodialysis (since more than 3 months)
- •Hyperphosphatemia controlled with only CaCO3
- •PO4 > 1,60 mmol/l, PCa < 2,37 mmol/l
- •patient able to understand and sign informed consent form
排除标准
- •PTH < 60 ou > 800 pg/ml (PTX)
- •Aluminium intoxication (aluminium level in blood > 0,5 µmol/l)
- •Score of aortic calcifications ≥ 20 (max 24)
- •Characterized intolerance with Renagel and/or Nicobion
- •Pregnant woman
- •Autoimmune disease
- •Patient known to have a bad drug compliance
- •Blood tests abnormality (thrombopenia <150 000, serum albumin <30g)
- •Hepatic tests abnormality
- •Transplant probably within 6 months
- •Patient who will need transplantation within 6 month
- •Patients receiving chemotherapy
- •Patients having a loss of dry weight of 3 kg in 3 months or 6 kg in 6 months.
研究组 & 干预措施
sevelamer
Titration phase with sevelamer (Renagel) with the aim of phosphatemia control in 4 weeks of treatment, with stable dose of calcic carbonate.
Increase of sevelamer dose up to 12 tablets, as follows:
0 morning, 2 noon, 2 evening (first week), then, 0 morning, 4 noon, 4 evening (second week), then, 2 morning, 4 noon, 4 evening (third week), then, 4 morning, 4 noon, 4 evening (fourth week).
干预措施: sevelamer (Drug)
sevelamer
Titration phase with sevelamer (Renagel) with the aim of phosphatemia control in 4 weeks of treatment, with stable dose of calcic carbonate.
Increase of sevelamer dose up to 12 tablets, as follows:
0 morning, 2 noon, 2 evening (first week), then, 0 morning, 4 noon, 4 evening (second week), then, 2 morning, 4 noon, 4 evening (third week), then, 4 morning, 4 noon, 4 evening (fourth week).
干预措施: cinacalcet (Drug)
nicotinamide
Titration phase with nicotinamide (Nicobion) with the aim of phosphatemia control in 4 weeks of treatment, with stable dose of calcic carbonate.
Increase of nicotinamide dose up to 4 tablets, as follows:
0 morning, 1 noon, 0 evening (first week), then, 0 morning, 1 noon, 1 evening (second week), then, 1 morning, 1 noon, 1 evening (third week), then, 1 morning, 2 noon, 1 evening (fourth week).
干预措施: nicotinamide (Drug)
nicotinamide
Titration phase with nicotinamide (Nicobion) with the aim of phosphatemia control in 4 weeks of treatment, with stable dose of calcic carbonate.
Increase of nicotinamide dose up to 4 tablets, as follows:
0 morning, 1 noon, 0 evening (first week), then, 0 morning, 1 noon, 1 evening (second week), then, 1 morning, 1 noon, 1 evening (third week), then, 1 morning, 2 noon, 1 evening (fourth week).
干预措施: cinacalcet (Drug)
结局指标
主要结局
The comparison between nicotinamide and Sevelamer was primarily to demonstrate the noninferiority of nicotinamide in terms of control of the phosphatemia observed during the 4th, 5th and 6th months before to introduce Cinacalcet ®.
时间窗: 6th months
次要结局
- To demonstrate noninferiority of nicotinamide in terms of effect on dyslipidemia (evaluated by the ratio LDL / HDL cholesterol), the risk of hypercalcemia (PCa> 2.37 mmol / l) and increase of phospho-calcic product (> 3 , 79 mmol/l).(6 th months and one year)
- To evaluate the difference between nicotinamide and sevelamer on vascular calcification(one year)
- Evaluate the percentage of population requiring use of cinacalcet® to control PTH (75-300 pg/ml). Evaluate his benefit on phosphatemia and calcemia control. Prevent the need for surgical PTX, and evaluate the additional cost of treatment by cinacalcet(6th months)
- Evaluate roles of metabolites of nicotinamide (efficacy and side effects) through another study(6th months and one year)
- Compare the cost-effectiveness ratio of these two treatments(one year)
- To evaluate the difference between nicotinamide and sevelamer on bone mass loss and fracture risk(one year)