A Randomized 4 Period Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D
研究概览
简要总结
This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours
详细描述
An open-label, randomized, four period sequential study of Triferic AVNU administered intravenously by three different administration schedules compared to continuous infusion over 3 hours
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Adult hemodialysis patients ≥18 years of age.
- •Signed informed consent to participate in the study.
- •Stable on hemodialysis prescription for ≥3 months.
- •Able to sustain hemodialysis 3x/week for 3 to 4 hours.
- •Hemoglobin concentration >9.5 g/dL.
- •Serum TSAT ≥20%.
- •Receiving hemodialysis via AV fistula or graft.
- •Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.
- •Able to receive intermittent heparin administration for anticoagulation of the dialysis circuit.
- •Serum TIBC ≥ 150 µg/dL.
排除标准
- •Active bleeding disorder (GI, skin, nasal...)
- •Receiving hemodialysis via catheter.
- •Receiving IV iron within 10 days of the first on-study hemodialysis treatment.
- •Receiving oral iron within 10 days of the first on-study hemodialysis treatment.
- •Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.
研究组 & 干预措施
Triferic AVNU infusion pre-dialyzer
Patients will receive one (1) 6.75 mg Fe dose of Triferic AVNU by continuous infusion over 3 hours into the predialyzer blood line.
干预措施: Triferic (Drug)
Triferic AVNU for injection at T=0 and T= 3 hours
Patients will receive two (2) doses of Triferic AVNU 3.4 mg IV (2.25 mL) at T=0 and T=3 hours of hemodialysis into the venous drip chamber.
干预措施: Triferic (Drug)
Triferic AVNU for injection at T=0
Patients will receive one (1) dose of Triferic AVNU 0.08 mg/kg IV, up to 6.75 mg Fe, at T=0 of hemodialysis into the venous drip chamber.
干预措施: Triferic (Drug)
Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours
Patients will receive three (3) doses of Triferic AVNU 2.25 mg Fe (1.5 mL) at T=0, T=1.5 and T=3.0 hours of hemodialysis into the venous drip chamber.
干预措施: Triferic (Drug)
结局指标
主要结局
Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D
时间窗: 8 hours
Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D
时间窗: 8 hours
次要结局
- Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D(8 hours)
- Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D(8 hours)
- Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D(8 hours)
- Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D(8 hours)