NCT01503736已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Definitive Phase III Study of the Effects of Ferric Citrate on Serum Phosphate in Subjects With End Stage Renal Disease
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
- 183
- 试验地点
- 5
- 主要终点
- Change in serum phosphorus at Day 56 as compared to baseline
研究概览
简要总结
The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).
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
- •Age>18 years and has a diagnosis of ESRD
- •On a three-times per week hemodialysis regimen
- •On a stable dose of a phosphate-binding agent for at least one month prior to study entry.
- •If on vitamin D supplementation or calcitriol, must be on a stable dose for at least one month prior to study entry.
- •Hct >= 20%
- •Serum Ca level of 8 mg/dL to 10.5 mg/dL
排除标准
- •Is pregnant or lactating
- •Clinically significant GI disorder
- •Has tertiary hyperparathyroidism or is immediately post-operative from a parathyroidectomy (within the first 3 months post-op or the plasma Ca is <7 mg/dL)
- •ferritin>800 ng/mL
- •Unstable medical condition unsuitable for the study in the opinion of investigator
- •Has been treated with an investigational agent within 30 days of enrollment
- •Has a history of documented iron allergy or hemochromatosis
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: ferric citrate (Drug)
4g/day
Experimental
Ferric Citrate for a total daily dose of 4g
干预措施: ferric citrate (Drug)
6g/day
Experimental
Ferric Citrate for a total daily dose of 6g
干预措施: ferric citrate (Drug)
结局指标
主要结局
Change in serum phosphorus at Day 56 as compared to baseline
时间窗: Day 56
次要结局
- Change in Ca x P product at Day 56 compared to baseline(Day 56)
- Change in serum phosphorus at Day 28 as compared to baseline(Day 28)
- Change in Ca x P product at Day 28 compared to baseline(Day 28)
- Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56(Day 56)
- Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28(Day 28)
研究者
研究点 (5)
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