A Randomized, Parallel Controlled Trial of Roxadustat Combined withSacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes of hemoglobin level before and after treatment
研究概览
简要总结
A randomized and parallel controlled trial design of comparing the new treatment group of Roxadustat combined with Sacubitril Valsartan Sodium Tablets with the traditional treatment group of recombinant human erythropoietin (EPO) combined with ACEI or ARB in Chinese patients with cardiorenal anemia syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as regular dialysis patients with cardiorenal anemia syndrome
- •Hemoglobin 60-110g / L (twice with an interval of at least 4 days);
- •Volunteered to participate
排除标准
- •Anemia caused by diseases other than CKD
- •Malignant tumors
- •Active liver disease
- •Rheumatic immune diseases in active stage
- •Hereditary or idiopathic angioedema
- •Systolic blood pressure≥180 mmHg;diastolic blood pressure≥110 mmHg
- •Acute myocardial infarction and unstable angina pectoris
- •Severe parathyroidism
- •Active peptic ulcer
- •taking aliskiren
- •Mental disease
- •Alcohol and drug abuse
- •Allergy to test drugs
研究组 & 干预措施
New treatment group(Roxadustat combined with Sacubitril Valsartan Sodium Tablets)
Roxadustat(FibroGen, China), 100mg (45-60kg) or 120mg (≥ 60kg) each time, three times a week, orally on an empty stomach in the morning. The initial dose of Sacubitril Valsartan Sodium Tablets(Novartis, China) is 50mg, once a day, taken on an empty stomach in the morning, and gradually titrated from the minimum dose to the maximum tolerated dose.
干预措施: Roxadustat;Sacubitril Valsartan Sodium Tablets; (Drug)
Traditional treatment group(EPO combined with ACEI or ARB )
Recombinant human erythropoietin (SEBOR, 10000 units / Branch) was injected subcutaneously once a week; Perindopril tablets (Servier, China), taken on an empty stomach, gradually titrated from the minimum dose to the maximum tolerated dose.
干预措施: EPO; ACEI / ARB (Drug)
结局指标
主要结局
Changes of hemoglobin level before and after treatment
时间窗: Day0-Day90
By detecting blood routine,calculate the changes of hemoglobin.Change value of hemoglobin level(g/L) = baseline hemoglobin level(g/L) - hemoglobin level after treatment(g/L)
Changes of ejection fraction before and after treatment
时间窗: Day0-Day90
Cardiac ejection fraction was measured by cardiac ultrasound before and after treatment，and change of cardiac ejection fraction(%) = baseline cardiac ejection fraction level(%) - post-treatment cardiac ejection fraction level(%)
Incidence of acute heart failure, acute myocardial infarction, severe hyperkalemia and severe anemia during treatment
时间窗: Day0-Day90
Incidence rate = number of patients with the events/ total number of patients included in the study in this group.
次要结局
未报告次要终点
研究者
Guangqun Xing,MD
Chief physician; Professor
The Affiliated Hospital of Qingdao University