| Trial ID: | L1111 |
| Source ID: | NCT05526157
|
| Associated Drug: |
Finerenone (Kerendia, Bay 948862)
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| Title: |
An Observational Study, Called FINEGUST, to Learn More About How People With Chronic Kidney Disease and Type 2 Diabetes Are Treated and How the Introduction of New Treatment Options, Like Finerenone, Impacts Clinical Practice
|
| Acronym: |
FINEGUST
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| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Chronic Kidney Disease|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Finerenone (Kerendia, BAY 948862)|DRUG: Sodium-glucose cotransporter 2 inhibitors (SGLT2i)|DRUG: Glucagon-like peptide-1 receptor agonists (GLP 1 RA)|DRUG: Steroidal mineral corticoid receptor antagonists (sMRA)|DRUG: Non-steroidal mineral corticoid receptor antagonists (nsMRA)
|
| Outcome Measures: |
Primary: Descriptive summary of baseline patient characteristics, Demographic (Age, Sex, Race and Socioeconomic status ) and clinical characteristics (markers of severity of T2D and of kidney dysfunction ) data will be collected., Baseline study periods I and II|Descriptive summary of patient comorbidities, History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, hypertension, hypercholesterolemia, Congestive heart failure, Severe liver disease, Other comorbidities measured by the Charlson or similar comorbidity indices. Lifestyle factors as Body mass index (BMI) or evidence of obesity, Smoking status, and alcohol abuse and alcohol abuse-related conditions, as available in each data source., Baseline study periods I and II|Descriptive summary of patient comedications, Medications for T2D, CKD and other relevant medications., Baseline study periods I and II | Secondary: Descriptive summary of changes over time in treatments in the new-user cohorts, From Day 1 until Censor Day (at the earliest of death, disenrolment, exclusion criteria during follow-up, or end of the study period) [up to 114 months for study period I and up to 39 months for study period II].|Descriptive summary of temporal changes in the baseline characteristics of medication-specific cohorts, Baseline up to 114 months for study period I and up to 39 months for study period II
|
| Sponsor/Collaborators: |
Sponsor: Bayer
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
50000
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2022-10-01
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| Completion Date: |
2024-09-05
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| Results First Posted: |
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| Last Update Posted: |
2024-10-15
|
| Locations: |
Optum CDM, Eden Prairie, Minnesota, 55344, United States|Many Locations, Multiple Locations, Denmark|Many Locations, Multiple Locations, Japan|Many Locations, Multiple Locations, Netherlands|Many Locations, Multiple Locations, Spain
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| URL: |
https://clinicaltrials.gov/show/NCT05526157
|
