An In-Depth Analysis of the Present Diagnostic and Therapeutic Landscape for Renal Anemia in China's Real-World Clinical Environment: A Multicenter Retrospective Cohort Investigation（DASHENG Study）
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Disease characteristics and current treatments of anemia in chronic kidney disease (CKD) patients in China.
研究概览
简要总结
Anemia affects the quality of life of CKD patients and increases the risk of CKD progression. we conducted a real-world study on patients with anemia in CKD to analyze the disease characteristics and treatment in Chinese patients with CKD-anemia.
详细描述
Anemia adversely affects the quality of life of CKD patients and increases the risk of CKD progression.
This study utilize data from approximately 20 medical centers across China. It aims to:
- Analyze the disease characteristics, current diagnostic and treatments in Chinese patients with CKD-anemia.
- Evaluate the safety and efficacy profiles of different drugs used for CKD-anemia.
- Explore the direct medical costs associated with CKD-anemia management within real-world clinical practice in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •CKD patients will be defined as those meeting any of the following criteria during the observation period:
- •diagnosis of CKD (e.g., "%chronic kidney disease%", "%chronic nephropathy%", "%renal failure%", "%nephritis%" for complete ICD-9/10 code mapping*)
- •record of hemodialysis (HD) or peritoneal dialysis (PD) (refer to Attachment 2 for dialysis identification algorithms)
- •≥2 eGFR measurements <60 mL/min/1.73m² (calculated using CKD-EPI equation) with ≥3-month interval (excluding acute kidney injury)
排除标准
- •Non-renal anemia due to trauma, traffic accidents, major hemorrhage, or other confirmed etiologies (e.g., acute hemorrhagic anemia, nutritional deficiency anemia, hemolytic anemia);
- •Diagnosis of acute kidney disease (AKD) without chronic kidney disease (CKD) comorbidity;
- •Incomplete critical data elements (including age, sex, or visit dates).
结局指标
主要结局
Disease characteristics and current treatments of anemia in chronic kidney disease (CKD) patients in China.
时间窗: 20230101-20241231
Disease characteristics and current treatments of anemia in chronic kidney disease (CKD) patients in China will beperformed to assess the proportions of CKD primary diseases, distribution of CKD stages, baseline Hb level distribution, and proportion of anti-anemia medication usage.
Incidence of Adverse Events according to CTCAE 5.0 (Safety profile of different anemia medications in CKD patients with anemia.)
时间窗: 20230101-20241231
An analysis will be performed to assess the safety according to CTCAE 5.0 .
次要结局
- Analyze the efficacy of different anemia drugs in CKD patients with anemia.(20230101-20241231)
- Explore the economic burden of anemia in CKD patients(20230101-20241231)
研究者
Wei Chen
Doctor
First Affiliated Hospital, Sun Yat-Sen University