NCT03062176撤回2 期
Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease (E-HART)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Peak oxygen consumption (PVO2)
研究概览
简要总结
Interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic kidney disease (End-stage renal disease and Heart fAilure - Anakinra Remodeling Trial) is a Phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, on cardiorespiratory fitness in patients with advanced chronic kidney disease and heart failure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •18 years or older
- •Chronic heart failure
- •Left ventricular ejection fraction less than 50%
- •C-reactive protein greater than or equal to 2 mg/L
- •Maintenance hemodialysis with a biocompatible membrane, acceptable dialysis adequacy (Kt/V > 1.2), and receipt of a stable hemodialysis prescription for at least 4 weeks OR chronic kidney disease stage IV/V (estimated glomerular filtration rate <30 mL/min/1.73m2)
排除标准
- •Inability to complete maximal cardiopulmonary exercise testing
- •Need for urgent or emergent care
- •Recent use of immunosuppressant, anti-inflammatory therapies or active rheumatologic disease
- •Allergy to rubber, latex, Escherichia coli or anakinra
研究组 & 干预措施
Active Treatment
Experimental
Anakinra (Kineret)
干预措施: Anakinra (Drug)
结局指标
主要结局
Peak oxygen consumption (PVO2)
时间窗: 6 months
Peak oxygen consumption during cardiopulmonary exercise
次要结局
- Heart Failure Hospitalization(6 months)
研究者
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