NCT00506441已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in 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
- 已完成
- 入组人数
- 245
- 试验地点
- 39
- 主要终点
- The Change in Serum Phosphorus From Week 12 to Week 16
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, flexible dose titration, 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, and is >=18 years old
- •Stable hemodialysis or peritoneal dialysis
- •Subjects has Stable phosphate control
- •Subjects on Stabilized phosphorus diet
- •Subjects undergoing regular dialysis treatment
- •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.
- •serum albumin level < 3.0g/dL
- •PTH level > 1000pg/mL
- •Hemoglobin level < 8mg/dL
- •A History of significant gastrointestinal motility problems
- •Biliary obstruction or proven liver dysfunction
- •A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies
- •A clinically significant severe lactose intolerance or sensitivity
- •A history of substance or alcohol abuse within the last year.
- •Seizure disorders
- •A history of drug or other allergy
- •using cholestyramine, colestipol or colesevelam
- •Schedule to receive a kidney transplant within the next 6 months
- •Participation 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
Experimental
干预措施: MCI-196 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The Change in Serum Phosphorus From Week 12 to Week 16
时间窗: 4 weeks (Week 12 to Week 16)
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
次要结局
- Change From Baseline in Serum Phosphorus(12 weeks (Week 0 to Week 12))
- Change From Baseline in PTH(12 weeks)
- Change From Baseline in Calcium(12 weeks)
- Change From Baseline in Calcium x Phosphorus Ion Product(12 weeks)
- Change From Baseline in Total Cholesterol(12 weeks)
- Change From Baseline in LDL Cholesterol(12 weeks)
- Change From Baseline in HDL Cholesterol(12 weeks)
- Change From Baseline in VLDL Cholesterol(12 weeks)
- Change From Baseline in Triglyceride(12 weeks)
- Incidence of Adverse Events(12 weeks (Week 0-12) and 4 weeks (Week 12-16))
研究者
研究点 (39)
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