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

Part of paid clinical trials in Whippany, New Jersey.

Sponsor
Bayer
Study ID
NCT06608212
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 9, 2024
Status verified
Apr 2026
Primary completion
Mar 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
150,000 participants (estimated)

Arms

  • Arm: Finerenone group
    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
  • Arm: Comparator group
    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 Measure

Time to the first occurrence of composite cardiovascular outcome [ Time Frame: Retrospective analysis from July 2021 to June 2025 ]

Locations (1)

FacilityCityStateZIPSite coordinators
BayerWhippanyNew Jersey07981-

Find similar trials in Whippany, NJ

By condition
Chronic kidney diseaseType 2 diabetes
By specialty
NephrologyKidney diseaseEndocrinologyMetabolic healthWeight loss
By research site
Bayer· Whippany, NJ

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