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Clinical Trial Details

Trial ID: L0898
Source ID: NCT05640180
Associated Drug: Finerenone (Kerendia, Bay94-8862)
Title: An Observational Study Called FLAMINgO to Learn More About the Treatment Combination of Finerenone and SGLT2 Inhibitors in People With Long-term Kidney Disease (Chronic Kidney Disease) Together With Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study Results
Acronym: FLAMINGO
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Type 2 Diabetes
Interventions: DRUG: Finerenone (Kerendia, BAY94-8862)|DRUG: Sodium-glucose cotransporter-2 inhibitors (SGLT2i)
Outcome Measures: Primary: Time to the first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death, From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months|Time to first occurrence of the composite endpoint of Cardiovascular (CV) death or non-fatal CV event (i.e. myocardial infarction, stroke, or hospitalization for heart failure), From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months | Secondary: Time to all-cause hospitalization, From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with a maximum follow-up time of 48 months|Time to all-cause mortality, From randomization up until death due to any cause, or censoring at the end of the study, with a maximum follow-up time of 48 months|Change in urine albumin-creatinine ratio (UACR) from baseline to Month 4, From baseline to Month 4|Time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease in eGFR of ≥ 57% from baseline over at least 4 weeks or renal death, From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 17847
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-11-23
Completion Date: 2023-12-20
Results First Posted:
Last Update Posted: 2024-01-08
Locations: Bayer, Whippany, New Jersey, 07981, United States
URL: https://clinicaltrials.gov/show/NCT05640180