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Clinical Trial Details

Trial ID: L1259
Source ID: NCT06278207
Associated Drug: Finerenone (Bay 94-8862)
Title: 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
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Type 2 Diabetes Mellitus
Interventions: DRUG: Finerenone (BAY 94-8862)
Outcome Measures: Primary: Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone., Sociodemographic characteristics such as age, sex, race and socio-economic status., 12 months before first prescription/dispensation of finerenone (index date)|Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone., 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), 12 months before first prescription/dispensation of finerenone (index date)|Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone., 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, 12 months before first prescription/dispensation of finerenone (index date) | Secondary: Proportion of finerenone initiators with and without UACR measurements at baseline, UACR=Urinary Albumin-to-Creatinine Ratio, 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|Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone., 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 transplant, 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., 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., 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., 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., 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 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
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 50000
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-05-15
Completion Date: 2025-10-31
Results First Posted:
Last Update Posted: 2025-04-13
Locations: Many Locations, Multiple Locations, New Jersey, 07981, United States|Bayer, Berlin, 13353, Germany|Many Locations, Multiple Locations, Japan
URL: https://clinicaltrials.gov/show/NCT06278207