An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States
- Conditions
- Type 2 Diabetes MellitusChronic Kidney Disease
- Interventions
- Registration Number
- NCT06608212
- Lead Sponsor
- Bayer
- Brief Summary
This is an observational study in which data from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are collected and studied.
In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time. It is common in people with Type 2 diabetes mellitus (T2D), a condition in which glucose levels rise in the blood. People who have T2D and CKD may also develop heart disease over time.
The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D in the US. It blocks the activity of a protein involved in worsening kidney function.
The participants in this study are allowed to take finerenone as part of their regular care from their doctors.
The main purpose of the study is to learn about how safe finerenone is and how well it works in people with CKD and T2D in routine medical care. To do this, researchers will collect information about the time to first occurrence of any of the following heart-related problems for participants in the US who are taking finerenone and those who are not taking it:
* Heart attacks
* Hospitalization due to heart failure The data will come from the electronic healthcare records of people with CKD and T2D in the US who are allowed to take finerenone after July 2021.
Researchers will track participants' data and will follow them until the occurrence of heart-related problems, the participant's data is no longer available, there is a change in the participant's treatment strategy, or the end of the study.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Finerenone group Finerenone (Kerendia, BAY948862) Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) initiating finerenone. Retrospective analysis using secondary data collection from existing healthcare data from the US. Considered data sources include the HealthVerity Chronic Kidney Disease Masterset Comparator group Others except finerenone Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) not using finerenone. Retrospective analysis using secondary data collection from existing healthcare data from the US. Considered data sources include the HealthVerity Chronic Kidney Disease Masterset
- Primary Outcome Measures
Name Time Method Time to the first occurrence of composite cardiovascular outcome Retrospective analysis from July 2021 to June 2025 The composite cardiovascular outcome includes an inpatient hospital diagnosis of fatal or nonfatal acute myocardial infarction or an inpatient hospitalisation with a primary diagnosis of heart failure.
- Secondary Outcome Measures
Name Time Method Time to occurrence of specific Urine Albumin-Creatine Ratio (UACR) decline thresholds Retrospective analysis from July 2021 to June 2025 Time to the first occurrence of a hospitalisation or emergency department visit with a diagnosis code for hyperkalaemia Retrospective analysis from July 2021 to June 2025 Time to the first occurrence of an inpatient hospital diagnosis of fatal or nonfatal acute myocardial infarction Retrospective analysis from July 2021 to June 2025 Time to the first occurrence of an inpatient hospitalisation with a primary diagnosis of heart failure Retrospective analysis from July 2021 to June 2025 Time to the first occurrence of an inpatient hospital or emergency department diagnosis of heart failure for participants without a history of heart failure Retrospective analysis from July 2021 to June 2025
Trial Locations
- Locations (1)
Bayer
🇺🇸Whippany, New Jersey, United States