NCT01514851已完成3 期
Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 259
- 主要终点
- Presence/absence of incidence of hypercalcemia up to 8 weeks
研究概览
简要总结
To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period.
- •Out-patient
- •Undergoing hemodialysis three times per week for at least previous 3 consecutive months
排除标准
- •Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after
- •Corrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 week after
- •Serum intact PTH (Parathyroid) of ≧1000 pg/mL at the start of the washout period
- •Pregnant woman, or lactating mother
- •Significant gastrointestinal disorders including known acute peptic ulcer
- •Liver dysfunction
- •History of cardiovascular or cerebrovascular diseases
- •Requiring treatment for hypothyroidism
研究组 & 干预措施
Arm 1
Experimental
750-2250mg/day, tid (three times a day), 8 weeks
干预措施: Lanthanum carbonate (BAY77-1931) (Drug)
Arm 2
Active Comparator
1500-4500mg/day, tid, 8 weeks
干预措施: Calcium carbonate (Drug)
结局指标
主要结局
Presence/absence of incidence of hypercalcemia up to 8 weeks
时间窗: up to 8 weeks
Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period
时间窗: baseline to week 8
次要结局
- Number of participants achieving target PSPL and time to achievement(up to 8 weeks)
- Serum calcium x phosphate product at the end of the double-blind treatment period(Week 8)
- Serum intact-PTH (Parathyroid) levels(Week 8)
- Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period(Week 8)
- Number of participants achieving the target serum calcium levels(Week 8)
- Safety variables will be summarized using descriptive statistics based on adverse events collection(8 weeks)
研究者
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