Effect of SGLT2 Inhibitors on Renal Anemia and Its Management in Patients With CKD in Japan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- First occurrence of anemia (composite anemia outcomes)
研究概览
简要总结
The objectives of the study are:
- To evaluate the association between Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitor use and the occurrence of anemia in patients with chronic kidney disease (CKD) using a nested case-control design with incidence density sampling.
- To evaluate anemia-related outcomes using a nested case-control-based analytical framework, including assessment of within-subject changes in anemia-related treatments and healthcare costs by comparing the period after study entry with the period after the index date (for cases) or matched reference date (for controls), and comparison according to SGLT2 inhibitor use:
A) Prescription patterns and treatment regimens for anemia, including analysis of medication types, dosing strategies, and duration of treatments B) Anemia-related healthcare costs C) Change in laboratory values
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
- •Have two consecutive estimated glomerular filtration rate (eGFR) measurements < 60 mL/min/1.73 m2 at least 92 days apart between April 17, 2014 and October 31,
- •Aged 18 years or older at the study cohort entry date.
- •Have at least one haemoglobin (Hb) measurement at the study cohort entry date or within 183 days before the study cohort entry date.
排除标准
- •Have less than 183 days of record history before the study cohort entry date.
- •Have any prescription record for an SGLT2 inhibitor at the study cohort entry date or within 183 days before the study cohort entry date
- •Have evidence of anemia at the study cohort entry date or within 183 days before the study cohort entry date.
- •Hemoglobin (Hb) < 13.0 g/dL for men or < 12.0 g/dL for women
- •Hematocrit (Ht) < 39% for men or < 36% for women
- •Have a history of prescribed anemia-related medications and treatments at the study cohort entry date or within 183 days before the study cohort entry date.
- •Have evidence of anemia-causing conditions other than chronic kidney disease (CKD) at the study cohort entry date or within 183 days before the study cohort entry date.
- •Confirm at least one instance of hemodialysis, peritoneal dialysis, or kidney transplantation at the study cohort entry date or within 183 days before the study cohort entry date.
研究组 & 干预措施
SGLT2 inhibitor users
干预措施: SGLT2 inhibitor (Drug)
SGLT2 inhibitor non-users
结局指标
主要结局
First occurrence of anemia (composite anemia outcomes)
时间窗: From the study cohort entry date to first event occurrence (for cases) or matched reference date (for controls), up to 13 years
The composite of anemia outcomes is defined as any of the following: * Hb \< 13.0 g/dL for men or \< 12.0 g/dL for women * Clinical diagnosis of anemia using ICD-10 diagnosis codes * Initiation of anemia treatment (Erythropoiesis-Stimulating Agents (ESAs), Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH) inhibitors, iron preparations, or red blood cell (RBC) transfusion
Time to the first occurrence of anemia (composite anemia outcomes)
时间窗: From the index date to first event occurrence or the end date of each individual's follow-up, up to 13 years
The composite of anemia outcomes is defined as any of the following: * Hb \< 13.0 g/dL for men or \< 12.0 g/dL for women * Clinical diagnosis of anemia using ICD-10 diagnosis codes * Initiation of anemia treatment (Erythropoiesis-Stimulating Agents (ESAs), Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH) inhibitors, iron preparations, or red blood cell (RBC) transfusion
次要结局
- Number of administered doses of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions(1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls))
- Anemia-related healthcare costs(1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls))
- Frequency of administration of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions(1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls))