Finerenone Research of Outcomes and Drug Utilization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50,000
- 试验地点
- 4
- 主要终点
- Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
研究概览
简要总结
This is an observational study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems.
The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone.
The data will come from a network of commercial electronic health records (EHRs) and national claims data in the United States and in Asia. They cover the period from July 1st, 2021 until the latest data cut available for each dataset. Only already available data is collected and studied. There are no required visits or tests in this study.
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
- •A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used
- •No recorded prescription for finerenone in the 12 months prior to the index date
- •Age of 18 years or older as of the index date
- •Evidence of T2D at any point before (and including) the index date.
- •CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:
- •A diagnosis code indicating CKD stage 2, 3, 4 or stage unspecified
- •two UACR tests results ≥ 30 mg/g separated by at least 90 days and by not more than 540 days
- •two different eGFR test results ≥ 15 mL/min/1.73 m2 AND < 60 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days
排除标准
- •- Kidney failure defined as follows:
- •Two different eGFR test results < 15 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days;
- •Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period);
- •A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant
研究组 & 干预措施
Adult patients with CKD and T2D who initiate finerenone
The data sources used include a network of commercial electronic health records (EHRs) and national claims data in Asia and in the United States.
干预措施: Finerenone (BAY 94-8862) (Drug)
结局指标
主要结局
Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
时间窗: 12 months before first prescription/dispensation of finerenone (index date)
Sociodemographic characteristics such as age, sex, race and socio-economic status.
Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
时间窗: 12 months before first prescription/dispensation of finerenone (index date)
Including heart diseases, lipid diseases, liver disease, hospitalization for acute kidney injury, dementia, body mass index, smoking status, alcohol abuse, and other comorbidities measured using comorbidities indexes (such as the Charlson comorbidity index)
Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
时间窗: 12 months before first prescription/dispensation of finerenone (index date)
In subcohorts of participants in co-medication between finerenone and other hypertensive and diabetic medications (SGLT2i, RAASi, GLP-1 RA, etc.), characterized by CKD stage, including a 15-25 ml/min/1.73 m2 eGFR subgroup.
Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
时间窗: 12 months before first prescription/dispensation of finerenone (index date)
Sociodemographic characteristics such as age, sex, race and socio-economic status.
Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
时间窗: 12 months before first prescription/dispensation of finerenone (index date)
Including heart diseases, lipid diseases, liver disease, hospitalization for acute kidney injury, dementia, body mass index, smoking status, alcohol abuse, and other comorbidities measured using comorbidities indexes (such as the Charlson comorbidity index)
Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
时间窗: 12 months before first prescription/dispensation of finerenone (index date)
In subcohorts of participants in co-medication between finerenone and other hypertensive and diabetic medications (SGLT2i, RAASi, GLP-1 RA, etc.), characterized by CKD stage, including a 15-25 ml/min/1.73 m2 eGFR subgroup.
次要结局
- Average UACR in the subcohort with UACR measurements(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Proportion of participants who down-titrate from 20 mg daily dose to a 10 mg dose daily at the 1, 3, 6, and 12 months mark(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Incidence rate of hospitalization for heart failure in participants with CKD and T2D that initiate finerenone.(From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months)
- Proportion of finerenone initiators with and without UACR measurements at baseline(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone.(From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months)
- Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone.(From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months)
- Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone.(From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months)
- Number of participants who initiate finerenone at a 10 mg dose daily(At day 0 (first prescription/dispensation of finerenone))
- Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Proportion of participants who up-titrate from 10 mg daily dose to a 20 mg dose daily at the 1, 3, 6, and 12 months mark(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Number of participants who initiate finerenone at a 20 mg dose daily(At day 0 (first prescription/dispensation of finerenone))
- Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Incidence rate of atrial fibrillation or flutter in participants with CKD and T2D that initiate finerenone.(From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months)
- Proportion of finerenone initiators with and without UACR measurements at baseline(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone.(From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months)
- Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone.(From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months)
- Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone.(From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months)
- Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Average UACR in the subcohort with UACR measurements(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Number of participants who initiate finerenone at a 10 mg dose daily(At day 0 (first prescription/dispensation of finerenone))
- Proportion of participants who up-titrate from 10 mg daily dose to a 20 mg dose daily at the 1, 3, 6, and 12 months mark(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Number of participants who initiate finerenone at a 20 mg dose daily(At day 0 (first prescription/dispensation of finerenone))
- Proportion of participants who down-titrate from 20 mg daily dose to a 10 mg dose daily at the 1, 3, 6, and 12 months mark(From first prescription/dispensation of finerenone (index date) until 12 months after index date)
- Incidence rate of hospitalization for heart failure in participants with CKD and T2D that initiate finerenone.(From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months)
- Incidence rate of hyperkalemia in participants with CKD and T2D that initiate finerenone.(From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months)
- Incidence rate of hospitalization associated with hyperkalemia in participants with CKD and T2D that initiate finerenone.(From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months)