Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Change in the hemoglobin from baseline
研究概览
简要总结
The purpose of this study is to conduct a a cohort study to evaluate the efficacy and safety of the efficacy and safety of roxadustat for the treatment of anemia, quality of life and cardiac function in patients with heart failure and chronic kidney disease.
详细描述
This is a cohort study in patients with anemia with heart failure complicated with chronic kidney disease, evaluating the the efficacy and safety of roxadustat. Patients were divided into roxadustat group and control group according to whether roxadustat was used or not. The efficacy and safety of roxadustat for the treatment of anemia, quality of life and cardiac function in patients with heart failure and chronic kidney disease will be evaluated.
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography, heart failure characteristics, diabetes status, kidney function, cardiac function, natriuretic peptide, dialysis, and additional co-morbidities, concomitant medications, and others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Male or female, aged ≥18 years at the time of consent
- •Weight between 45-160kg
- •Definite diagnosis of heart failure: according to the diagnostic criteria for heart failure in "Chinese Heart Failure Diagnosis and Treatment Guidelines 2018"
- •eGFR <60mL/min/1.73 m^2 by CKD-EPI.
- •Diagnosed anemia: male hemoglobin <130 g/L, non-pregnant female hemoglobin <120 g/L.
- •Provision of signed informed consent prior to any study specific procedures.
排除标准
- •Acute or chronic active bleeding 6 months before enrollment.
- •Anemias due to thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, ect.
- •Thromboembolism requiring anticoagulation.
- •Severe Infection.
- •Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment).
- •Severe malnutrition.
- •Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding.
- •Patients who have received roxadustat treatment or are allergic to roxadustat.
研究组 & 干预措施
Roxadustat group
Roxadustat group: patients with heart failure and chronic kidney disease and anemia treated with roxadustat and other anemia correction drugs.
干预措施: Roxadustat (Drug)
Roxadustat group
Roxadustat group: patients with heart failure and chronic kidney disease and anemia treated with roxadustat and other anemia correction drugs.
干预措施: Recombinant human eythropoietin and/or Iron agents (Drug)
Control group
Control group: patients with heart failure and chronic kidney disease and anemia who were treated with other drugs include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)
干预措施: Recombinant human eythropoietin and/or Iron agents (Drug)
结局指标
主要结局
Change in the hemoglobin from baseline
时间窗: up to 8 week
Hemoglobin is calculated by the routine blood test
次要结局
- Change in Left atrial volume(Up to 24 weeks)
- Change in Left atrial volume index(Up to 24 weeks)
- Change in Left Ventricular Diastolic Function(Up to 24 weeks)
- Change in Low-density lipoprotein（LDL）(Up to 8 weeks)
- Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)(Up to 8 weeks)
- Change in Left Ventricular End-Diastolic Diameter(Up to 24 weeks)
- Change in Serum ferritin(Up to 8 weeks)
- Change in Left Ventricular Systolic Function(Up to 24 weeks)
- Change in Transferrin saturation(Up to 8 weeks)
研究者
Jingyi Ren
Professor
China-Japan Friendship Hospital