A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 68
- 主要终点
- Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)
研究概览
简要总结
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 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.
- •Body Mass Index (BMI) <=16.0 kg/m2 or >=40.0 kg/m2
- •A current or 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
1
干预措施: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug)
2
干预措施: Placebo (Drug)
3
干预措施: Another phosphate binder (Sevelamer) (Drug)
结局指标
主要结局
Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)
时间窗: week16 minus week12
ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.
次要结局
- Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)(week12 minus week0)