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Clinical Trial Details

Trial ID: L1271
Source ID: NCT05703880
Associated Drug: Finerenone (Kerendia, Bay948862)
Title: An Observational Study Called FIRST-2.0 to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Acronym: FIRST-2
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Type 2 Diabetes Mellitus
Interventions: DRUG: Finerenone (Kerendia, BAY948862)
Outcome Measures: Primary: Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in the US., Up to 365 days|Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in the US., Up to 365 days|Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in the US., Up to 180 days | Secondary: Incidence rate of composite renal outcomes, Up to 18 months|Incidence rate of composite cardiovascular outcomes, Up to 18 months|Number of patients who initiate finerenone using a 10 mg dose and number of patients who have up-titrated to a 20 mg dose by 1, 3, 6, and 12 months, respectively., Up to 18 months|Number of patients who initiate finerenone using a 20 mg dose and number of patients who have down-titrated to a 10 mg dose by 1, 3, 6, and 12 months, respectively, Up to 18 months|Incidence rate of hyperkalemia, Up to 18 months|Incidence of hospitalization associated with a hyperkalemia event, Up to 18 months|Change in UACR between baseline, at 4 months and end of follow up visit after initiating finerenone, UACR: Urine Albumin to Creatinine Ratio, Up to 18 months|Change in eGFR between baseline, at 4 months and end of follow up visit after initiating finerenone, eGFR: Estimated Glomerular Filtration Rate, Up to 18 months|Change in level of serum potassium between baseline and end of follow up visit after initiating finerenone, Up to 18 months|Incidence rates of the respective component outcomes of the CV and renal composite outcomes, Up to 18 months|Incidence rate of proliferative diabetic retinopathy in patients who initiate finerenone with prior non-proliferative diabetic retinopathy, Proliferative diabetic retinopathy is identified by the occurrence of an inpatient or outpatient diagnosis code for proliferative diabetic retinopathy., Up to 18 months
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 15948
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2024-10-01
Results First Posted:
Last Update Posted: 2024-10-18
Locations: OM1 Real-World Data Cloud (RWDC), Boston, Massachusetts, 02116, United States|Optum electronic health records (EHR) database, Eden Prairie, Minnesota, 55344, United States
URL: https://clinicaltrials.gov/show/NCT05703880

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress