NCT00234702已完成2 期
A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Lanthanum Carbonate for the Reduction of Serum Phosphorus in Subjects With Stage 3 and 4 Chronic Kidney Disease Who Have Elevated Serum Phosphorus Levels
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 84
- 试验地点
- 10
- 主要终点
- Serum phosphorus levels at 8 weeks.
研究概览
简要总结
Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate. The body's attempt to adjust to an increased level of phosphate in the blood can result in elevated levels of hormones and minerals resulting in serious clinical consequences. This study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared to placebo.
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
- •Under a physician's care for CKD for > 2 months and are not expected to begin dialysis for 4 months
- •Screening estimated GFR of 15-59 mL/1.73 m2
- •Serum phosphorus >= 4.7 mg/d following washout
排除标准
- •Requiring treatment with cinacalcet HCI or compounds containing phosphate, aluminum, calcium or magnesium
- •Rapidly progressing glomerulonephritis
- •Cirrhosis or other clinically significant liver diseases
- •Past or present uncontrolled peptic ulcer, Crohn's disease, malignancy or recent GI bleed
研究组 & 干预措施
1
Experimental
干预措施: Lanthanum carbonate (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Serum phosphorus levels at 8 weeks.
时间窗: 8 weeks
次要结局
- PTH levels, calcium-phosphorus product.(8 weeks)
研究者
研究点 (10)
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