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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 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150000

Last updated 2026-04-13

No results posted yet for this 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.

Conditions

Interventions

DRUG

Finerenone (Kerendia, BAY948862)

Follow clinical practice/administration.

DRUG

Others except finerenone

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

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-09
Primary Completion
2025-03-31
Completion
2026-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06608212 on ClinicalTrials.gov