A Randomized, Open-label, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside/Ferric Derisomaltose and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (Phosphare-IDA-05)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)
研究概览
简要总结
The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).
详细描述
This trial was designed to evaluate the effect of IV iron isomaltoside/ferric derisomaltose compared with IV ferric carboxymaltose on s-phosphate in subjects with IDA caused by different etiologies.
The subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or two IV doses of ferric carboxymaltose (one dose 750 mg at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). The study subjects were monitored for up to 35 days from baseline.
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Iron isomaltoside/ferric derisomaltose
Administered IV
干预措施: Iron isomaltoside/ferric derisomaltose (Drug)
Ferric carboxymaltose
Administered IV
干预措施: Ferric carboxymaltose (Drug)
结局指标
主要结局
Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)
时间窗: Baseline to day 35
Safety The incidence of hypophosphatemia (defined as s-phosphate \<2 mg/dL) at any time from baseline up to day 35.
次要结局
- Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)(Baseline to day 35)
- Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)(Baseline to day 35)
- Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)
- Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)
- Change From Baseline in Fractional Phosphate Urinary Excretion(Baseline, days 1, 7, 8, 14, 21, and 35)
- Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)
- Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)
- Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)
- Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)
- Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)
- Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)
- Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions(Baseline to day 35)
- Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)
- Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)
- Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)
- Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35(Baseline, days 1, 7, 8, 14, 21, and 35)