NCT01110629已完成3 期
Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lanthanum Carbonate 750 to 2250 mg in Patients With Chronic Kidney Disease Not on Dialysis Who Develop 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
- 发起方
- Bayer
- 入组人数
- 143
- 主要终点
- The change from baseline in serum phosphate concentrations
研究概览
简要总结
The objective of this study is to investigate the efficacy and safety of lanthanum carbonate 750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.
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, Care Provider, Investigator)
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
- •Male and female patients aged 20 years or above at the time of informed consent
- •Chronic Kidney Disease patients with Epidermal growth factor receptor (eGFR) under 60 ml/min/1.73m2 (stage 3, 4 and 5) who have not been on dialysis
- •Patients who had been in the care of a physician for Chronic Kidney Disease for >2 months and was not expected to begin dialysis for at least 4 months
- •Patients with serum phosphate levels 5.6 mg/dL to 11.0 mg/dL at Week -4 (Visit 1) or Week -2 (Visit 2)
排除标准
- •Patients with hypocalcemia or hypercalcemia (corrected serum calcium level of < 7.0 mg/dL or >/- 11.0 mg/dL) at Week -2 (Visit 2).
- •Significant renal impairments
- •Had acute renal failure within 3 months of Run-in period
研究组 & 干预措施
Arm 1
Experimental
干预措施: Fosrenol (Lanthanum Carbonate, BAY77-1931) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The change from baseline in serum phosphate concentrations
时间窗: Week 8
次要结局
- Serum intact PTH level(Week 0, Week 2, Week 4, Week 6, Week 8)
- Phosphate excretion in urine(Week 0, Week 4, Week 8)
- Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)(Week 0, Week 2, Week 4, Week 6, Week 8)
- Change in serum Calcium x Phosphor product(Week 0, Week 2, Week 4, Week 6, Week 8)
研究者
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