A Prospective Cohort Study of Roxadustat for Anemia in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mean value of Hb levels over time
研究概览
简要总结
A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the treatment of renal anemia, but there is a lack of evidence from cohort studies. A prospective cohort study is planed to conduct to evaluate the efficacy and safety of Roxadustat for renal anemia in the real world.
详细描述
The prevalence of anemia in patients with chronic kidney disease (CKD) (15.4%) is twice that of the general population (7.6%), and the degree of anemia increases with the severity of CKD. A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the treatment of renal anemia, but there is a lack of evidence from cohort studies. A prospective cohort study is planed to conduct to evaluate the efficacy and safety of Roxadustat for renal anemia in the real world. It is planned to continuously recruit patients with renal anemia in Shenzhen Second People's Hospital from October 2020 to June 2023. The treatment of anemia will be recorded (Roxadustat or erythropoietin), and the observation period is one year. Collect the patient's demographic characteristics, drug dosage, adjustment plan, hemoglobin. The main outcome indicators were: the average change in Hb from baseline to 28-52 weeks, and the Hb response rate reached during two consecutive visits; the secondary outcome indicators were: the maintenance rate of the target Hb level, iron metabolism indicators, 0 to 8 weeks of Hb level increase rate, dose adjustment and safety indicators. The generalized additive mixed model of repeated measures was used to analyze the changes and differences of outcome indicators in different groups. Expected results: In the cohort study, the effectiveness and safety of roxastat in the treatment of renal anemia, the starting dose and the adjustment plan, provide a basis for guiding the clinical safe and effective application of roxastat.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •the patient did not receive ESA treatment.The average Hb level of the last two (at least 7 days before the start of the study treatment and during the screening period) was <10 g/dL.
- •Or patients who have received ESA:
- •Patients with renal anemia who received ESA for at least 4 weeks within the approved dose range in China before the screening evaluation.
- •The average Hb level of the last two (at least 7 days before the start of the study treatment and during the screening period) >=7 g/dL and <=12.0 g/dL;
- •The expected survival time is more than 1 year;
排除标准
- •a history of severe, chronic, end-stage or uncontrolled autoimmune liver disease, Child Pugh score was grade C, or with active hepatitis;
- •preparing for pregnancy or pregnancy or lactation;
- •having anemia caused by any other disease other than CKD, such as thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, tumor-related anemia, chemotherapy-related anemia, and myelodysplastic syndrome;
- •malignant tumor, such as prostate cancer, breast cancer, renal cell cancer or any other malignant tumor history or diagnosed
- •.Any red blood cell infusion during the screening period;
- •The patient is known to be allergic to the active substance (Roxadustat) or any excipient of the product;
研究组 & 干预措施
Roxadustat
treatment with roxadustat
干预措施: Roxadustat (Drug)
erythropoietin
treatment with erythropoietin
干预措施: erythropoietin (Drug)
结局指标
主要结局
Mean value of Hb levels over time
时间窗: Up to Week 52
Hb will be measured throughout the period.
Achievement rate for target Hb level
时间窗: Up to Week 52
Percent of participants who achieved target Hb level (≥10.0 ).
次要结局
- Change from baseline in Hemoglobin (Hb) levels(Up to Week 52)
- Mean Hb levels at 4 weeks after using roxadustat(At Week 4)
- the dose of Roxadustat used(Up to Week 52)
- Number of Participants with adverse events(Up to Week 52)
- Mean Hb levels at 8 weeks after using roxadustat(At Week 8)
- the proportion of patients with different Hb levels(Up to Week 52)
- Concentration of Serum iron(Up to Week 52)
- The proportion of patients with low response to ESA(Up to Week 52)