protocolSection identificationModule nctId: NCT06278207, orgStudyIdInfo id: 22731, briefTitle: 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, acronym: FINEROD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: This is an observational study, in which data from people in Japan 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 Japan. They cover the period from July 1st, 2021 until September 2023. Only already available data is collected and studied. There are no required visits or tests in this study., conditionsModule conditions: Chronic Kidney Disease, conditions: Type 2 Diabetes Mellitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Finerenone (BAY 94-8862), outcomesModule primaryOutcomes measure: Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone., primaryOutcomes measure: Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone., primaryOutcomes measure: Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone., secondaryOutcomes measure: Proportion of finerenone initiators with and without UACR measurements at baseline, secondaryOutcomes measure: Mean UACR in the subcohort with UACR measurements, secondaryOutcomes measure: Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone., secondaryOutcomes measure: Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone., secondaryOutcomes measure: Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone., secondaryOutcomes measure: Number of participants who initiate finerenone at a 10 mg dose daily, secondaryOutcomes measure: Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark, secondaryOutcomes measure: 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, secondaryOutcomes measure: Number of participants who initiate finerenone at a 20 mg dose daily, secondaryOutcomes measure: Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark, secondaryOutcomes measure: 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, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bayer, status: RECRUITING, city: Berlin, zip: 13353, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Many Locations, status: COMPLETED, city: Multiple Locations, country: Japan, hasResults: False