NCT00436683已完成2 期
An Open Label, Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 15
- 主要终点
- Assessment of intolerance
研究概览
简要总结
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.
The purpose of this study is to determine how well a range of different doses of fermagate are tolerated by the subjects in the trial.
详细描述
High levels of phosphate in the blood are linked with serious effects, due to calcium imbalances (high levels of parathyroid hormone (PTH), bone disease, formation of calcium deposits in the body, and blood-vessel disease.
Current guidelines indicate that blood phosphorus levels should be maintained between 1.13 to 1.78 mmol/L in patients who receive hemodialysis.
The purpose of this study is to determine the range of dosages which are tolerated by patients with hyperphosphatemia, undergoing haemodialysis.
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
- •Male or female subjects on active haemodialysis, aged 18 years or over who are able to comply with study procedures
- •Written informed consent given
- •On a stable haemodialysis regimen (three times per week) for at least 3 months and be unlikely to change their dialysis prescription during the study period
- •On a stable dose of phosphate binder for at least 1 month prior to screening
- •Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium- or iron-containing products and preparations, other than the study medication
- •Willing to avoid any intentional changes in diet such as fasting, dieting or overeating
- •On a dialysate magnesium ion concentration of ≤1.0 mmol/L for at least 1 month prior to screening
排除标准
- •Received a cardiac transplant
- •Heart failure according to New York Heart Association (NYHA) Functional IV Classification
- •Participation in any other clinical trial using an investigational product or device within the previous 4 weeks
- •A significant history of alcohol, drug or solvent abuse in the opinion of the investigator
- •Any disease or condition, physical or psychological, which in the opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn
- •Clinically significant laboratory findings (at screening for this subject population) in the opinion of the investigator
- •Any history of recent clinically significant malignancy
- •A significant illness (excluding renal disease) in the 4 weeks before screening
- •A history of poorly controlled epilepsy
- •Female subjects who are lactating or pregnant. Women of childbearing potential (pre-menopausal and not surgically sterilised) unless they are using a reliable contraceptive method, that is, barrier methods, hormones or intrauterine device
- •Allergy to magnesium iron hydroxycarbonate or sevelamer or any component of the formulations
- •Any condition that affects the reliability of measuring QT interval, for example, an irregular heart rhythm such as atrial fibrillation or frequent ectopic activity
研究组 & 干预措施
2
Active Comparator
Dose titration
干预措施: Sevelamer HCl (Drug)
1
Experimental
Dose titration on active
干预措施: Fermagate (Drug)
结局指标
主要结局
Assessment of intolerance
时间窗: 10 weeks
次要结局
- Assessment of QTc interval(10 weeks)
- Change from baseline in serum electrolytes(10 weeks)
- Change from baseline in parathyroid hormone (PTH)(10 weeks)
- Reduction of serum magnesium removal during dialysis(10 weeks)
研究者
研究点 (15)
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