NCT00542386已完成3 期
A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 642
- 试验地点
- 73
- 主要终点
- The Change in Serum Phosphorus
研究概览
简要总结
This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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, 18 years of age or over
- •Clinically stable haemodialysis or peritoneal dialysis
- •Stable phosphate control
- •On a stabilised phosphorus diet
- •Female and of child-bearing potential have a negative serum pregnancy test
- •Male subjects must agree to use appropriate contraception
排除标准
- •Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
- •A a serum albumin level<30.0g/L
- •A PTH level >1000pg/mL
- •A body mass index (BMI)<= 16.0kg/㎡ or =>40.0kg/㎡
- •A serum LDL-C level >4.94mmol/L(190mg/dL)
- •A serum triglycerides level >6.76mmol/L (600mg/dL)
- •A History of significant gastrointestinal motility problems
- •A positive test for HIV 1 and 2 antibodies
- •A history of substance or alcohol abuse within the last year
- •Seizure disorders
- •A history of drug or other allergy
- •A temporary catheter as a vascular access
- •Participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Drug)
1
Experimental
干预措施: MCI-196 (Drug)
结局指标
主要结局
The Change in Serum Phosphorus
时间窗: 12 weeks
The change from baseline to week 12
The Change in LDL-cholesterol
时间窗: 12 weeks
The percentage change from baseline to week 12
次要结局
- The Change in Total-cholesterol(12 weeks)
- The Change in HDL-cholesterol(12 weeks)
- The Change in Triglycerides(12 weeks)
- The Change in PTH(12 weeks)
- The Change in Ca(12 weeks)
- The Change in Ca x P Ion Product(12 weeks)
- The Incidence of Adverse Events(12 weeks)
研究者
研究点 (73)
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