NCT00451295终止3 期
A Phase III, Double-Blind, Multi-Centre, Randomised, Parallel Group Design, Placebo-Controlled, Flexible Dose Study of MCI-196 in Combination With a Ca-Based Phosphate Binder in CKD Stage V Subjects on Dialysis With Hyperphosphatemia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Serum phosphorus change compared to placebo from baseline to week 12.
研究概览
简要总结
This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 80 years of age.
- •Stable phosphate control using Calcium-based phosphate-binding medication only.
- •The subject is undergoing regular dialysis treatment.
- •On a stabilised phosphorus diet.
- •If female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant.
- •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/m
- •Current or a history of significant gastrointestinal motility problems
- •A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
- •A history of substance or alcohol abuse within the last year.
- •Seizure disorders.
- •Using phosphate binder medication other than calcium based phosphate binders
- •Using colestyramine, colestipol or colesevelam
- •A history of drug or other allergy
- •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 the informed consent.
研究组 & 干预措施
1
Placebo Comparator
干预措施: Placebo (Drug)
2
Experimental
干预措施: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug)
结局指标
主要结局
Serum phosphorus change compared to placebo from baseline to week 12.
时间窗: 12 weeks
次要结局
- Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters.(12 weeks)
研究者
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