An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
- Conditions
- Chronic Kidney DiseaseType 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT06278207
- Lead Sponsor
- Bayer
- Brief Summary
This is an observational study, in which data from people in Japan 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 Japan. They cover the period from July 1st, 2021 until March 2024. Only already available data is collected and studied. There are no required visits or tests in this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50000
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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
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No recorded prescription for finerenone in the 12 months prior to the index date
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Age of 18 years or older as of the index date
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Evidence of T2D at any point before (and including) the index date.
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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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult patients with CKD and T2D who initiate finerenone Finerenone (BAY 94-8862) The data sources used include a network of commercial electronic health records (EHRs) and national claims data in Japan and in the United States.
- Primary Outcome Measures
Name Time Method Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone. 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. 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. 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
- Secondary Outcome Measures
Name Time Method 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 Any of the following:
≥ 2 outpatient eGFR measurements of \< 15 mL/min/1.73 m2 separated by at least 90 days; Record of dependence on dialysis (at least 3 sessions over at least 90 days); Diagnosis records of kidney failure or CKD stage 5; Record of kidney transplantDrug 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 Depending on the database used, this includes incidence of drug use, initiation of treatment measured by drug prescription, drug dispensation, or a combination of both depending on data availability, dosing regimen, treatment persistence and non-persistence, and implementation measured as the proportion of days covered.
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 UACR=Urinary Albumin-to-Creatinine Ratio
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 Acute myocardial infarction, identified as an inpatient hospital diagnosis of fatal or non-fatal acute myocardial infarction. Congestive heart failure, identified as an impatient hospital or emergency department diagnosis of heart failure and stratified by new-onset or recurrent heart failure.
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 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 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 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 Number of participants who initiate finerenone at a 20 mg dose daily At day 0 (first prescription/dispensation of finerenone)
Trial Locations
- Locations (2)
Many Locations
🇯🇵Multiple Locations, Japan
Bayer
🇩🇪Berlin, Germany