NCT04046263已完成4 期
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Serum Phosphate at Baseline
研究概览
简要总结
Prospective pilot study to determine if changing the phosphate binder to sucroferric oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in peritoneal dialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •On peritoneal dialysis at least 3 months with a Kt/V of ≥ 1.7
- •Use of Automated Peritoneal Dialysis
- •Serum phosphate > 5.5 mg/dL or <5.5 mg/dL on a binder other than velphoro
- •Serum albumin ≤ 3.7 g/dL
- •Able to provide consent
- •Ability to complete self-reported questionnaire
排除标准
- •Inadequate dialysis
- •Current use of sucroferric oxyhydroxide
- •Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 6 months
- •Active malignancy
- •Recent episode of peritonitis
- •Pregnancy or planning to become pregnant
- •Anticipated kidney transplantation within 6 months
- •Factors judged to limit adherence to interventions
- •Known adverse side effect to sucroferric oxydroxide
研究组 & 干预措施
Intervention
Experimental
Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal.
干预措施: Sucroferric Oxyhydroxide Chewable Tablet (Drug)
结局指标
主要结局
Serum Phosphate at Baseline
时间窗: Baseline
Serum phosphate at baseline
Serum Phosphate at 6 Months
时间窗: 6 months
Serum phosphate at end of study (6 months)
次要结局
- Serum PTH(Baseline, 6 months)
- Serum Albumin(Baseline, 6 months)
- Serum FGF23(6 months)
- Serum Prealbumin(6 months)
研究者
研究点 (1)
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