EUCTR2016-004147-37-DE进行中（未招募）1 期
Intravenous iron in patients with heart failure and reduced ejection fraction (HFREF) plus iron deficiency:Effects upon phosphate and FGF23 metabolism - Iron Turtle
Center for Translational & Clinical Research Aachen (CTC-A)0 个研究点目标入组 24 人开始时间: 2016年11月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Written informed consent.
- •- Age > 18 yrs
- •- Symptomatic HFREF (LV ejection fraction < 45%) with optimal medical therapy (OMT) for at least 2 months
- •- Iron deficiency as indicated by by ferritin <100 ng/mL or ferritin 100-299 ng/ml when TSAT <20% and Hb value < 13mg/dl (women) and <14 mg/dl (men)
- •- Group A: Stable CKD for at least 2 months, defined by eGFR (CKD-EPI formula) as 15-60 ml/min/1,73 m3 (CKD III, IV, V-non D)
- •- Group B: patients with stable eGFR > 60 ml/min/1,73 m3
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •- Known hypersensitivity to ferric carboxymaltose or any constituents of the formulation,
- •- Plasma Phosphate < 2.5 mg/dL at screening,
- •- Renal replacement therapy/transplantation,
- •- Pregnancy or lactation
- •- iron substitution therapy or erythropoetin (epo) therapy within 6 weeks before
- •- participation in another clinical trial with an experimental drug
- •- expectation of missing compliance
- •- alcohol or drug abuse
- •- The subject is mentally or legally incapacitated
- •- patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative
研究者
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