NCT07346547尚未招募4 期
Registry of Daprodustat in Chronic Kidney Disease (CKD) Anemia for Understanding Real-World Evidence (REDCURE)
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 384
- 主要终点
- Unit Change in Hb
研究概览
简要总结
A local registry on CKD-associated anemia aims to provide real-world insights into disease burden, treatment patterns, and outcomes at the national level. It helps capture variations in anemia severity with CKD stages, therapeutic practices and their response. It also supports evidence-based decision-making, identifies gaps in care, and informs locally relevant guidelines and policy planning to improve patient outcomes with oral novel therapy i.e. daprodustat
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adults ≥ 18 years
- •Diagnosed CKD-associated anemia Chronic Kidney Disease (CKD) diagnosed as per KDIGO criteria, including: CKD stages G3-G5 (based on eGFR)
- •Patients on hemodialysis (HD) or peritoneal dialysis (PD)
- •Post-kidney transplant patients with CKD
- •Receiving or initiating Daprodustat therapy (new start or switch therapy)
- •CKD stages 3-5, dialysis patients (HD/PD), or post-transplant with CKD anemia
- •Able and willing to provide informed consent
排除标准
- •Acute Kidney Injury (AKI) without underlying chronicity
- •Hematologic disorders not related to CKD (e.g hemolytic anemia, aplastic anemia)
- •Refusal or inability to provide consent
- •Current enrollment in an interventional trial that restricts real-world data collection
- •Life expectancy < 3 months, where follow-up is not feasible
- •Known contraindications to Daprodustat as per local prescribing information
研究组 & 干预措施
Daprodustat arm for CKD anemia patients
Active Comparator
Daprodustat arm for CKD anemia patients
干预措施: Daprodustat (Drug)
结局指标
主要结局
Unit Change in Hb
时间窗: 3 months
Hemoglobin response to therapy
次要结局
- Frequency of MACE ( Major Adverse Cardiovascular Events)(3 months)
研究者
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