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

NCT06608212 · tracked via the Priya Life Science USA tracker

Sponsor

Bayer

Phase

Observational

Started

2024-10-09

Last updated

2026-07-01

Condition(s) studied

Chronic Kidney DiseaseType 2 Diabetes Mellitus

Investigational drug(s) / intervention(s)

Finerenone (Kerendia, BAY948862)Others except finerenone

Finerenone (Kerendia, BAY948862): Follow clinical practice/administration.

Others except finerenone: Follow clinical practice/administration. The non-use finerenone treatment strategy will require individuals to be free of finerenone use.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion criteria on or before Time 0 (Time 0 = finerenone initiation date) : * Active registration or continuous enrolment for at least 365 days in the data source before Time 0 (days \[-365, 0\]) * No recorded use of finerenone before Time 0 (days \[-all available, 0\]) * Aged 18 years or older on Time 0 * Diagnosis of T2D at any time on or before Time 0 (days \[-all available, 0\]) * Having a diagnosis code indicating CKD stage 1, 2, 3, 4, or stage unspecified on or before Time 0 (days \[-all available, 0\]) Exclusion criteria on or before Time 0: * Finerenone users who are hospitalized or admitted for an emergency department visit on Time 0 * Type 1 diabetes (T1D) at any time on or before Time * Evidence of end-stage kidney disease (ESKD) at any time on or before Time 0 * A diagnosis of kidney cancer at any time on or before Time 0 * A diagnosis of adrenal insufficiency at any time on or before Time 0 * Evidence of hepatic impairment at any time on or before Time 0 * An eGFR measurement \< 25 mL/min/1.73 m2 on or in the 90 days before Time 0 * Evidence of recent increased serum potassium or hyperkalaemia * Use of a strong CYP3A4 inhibitor on or in the 183 days before Time 0 * Evidence of pregnancy measured on or in the 40 weeks before Time 0

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Bayer	Whippany	New Jersey

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06608212 on ClinicalTrials.gov ↗ ← All trials in the USA