A Prospective, Randomized, Open-label, Multi-center, Controlled Clinical Trial of the Safety and Efficacy of Physiological Iron Maintenance in End Stage Renal Disease (ESRD) Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS
研究概览
简要总结
In maintenance hemodialysis patients, regular administration of parenteral iron by addition of soluble ferric pyrophosphate (SFP) to the dialysate, when compared to conventional dialysate, is effective in preventing the development of iron deficiency, thereby maintaining hemoglobin level; is clinically safe and does not lead to oxidative stress or inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Subjects with end stage renal disease undergoing maintenance hemodialysis three times a week.
- •Subjects who have required IV iron at any time in the 2 months preceding enrollment.
排除标准
- •Subjects with absolute iron deficiency at the time of enrollment In hemodialysis subjects "absolute iron deficiency"
- •Subjects with a current malignancy involving sites other than skin.
- •Subjects with a history of drug or alcohol abuse within the last 6 months
研究组 & 干预措施
SFP dialysate
dialysate with added soluble ferric pyrophosphate (SFP)
干预措施: soluble ferric pyrophosphate (SFP) (Drug)
standard dialysate
standard dialysate without soluble ferric pyrophosphate (SFP)
干预措施: placebo (Other)
结局指标
主要结局
TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS
时间窗: 36 weeks
Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of subjects affected are listed only. The details of the types of events that took place are reported in the Adverse Events section.
TOTAL NUMBER OF ADVERSE EVENTS
时间窗: 36 weeks
Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of events are listed only. The details of the types of events that took place are reported in the Adverse Events section.
次要结局
未报告次要终点
研究者
Ajay Gupta
Ajay Gupta, MD
Charles Drew University of Medicine and Science