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NCT Number: NCT06608212

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Type 2 Diabetes Mellitus Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayer

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Finerenone (Kerendia, BAY948862)

Drug

Follow clinical practice/administration.

Others except finerenone

Drug

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

Primary outcomes

  1. Time to the first occurrence of composite cardiovascular outcome

    Time frame: 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 outcomes

  1. Time to the first occurrence of an inpatient hospital diagnosis of fatal or nonfatal acute myocardial infarction

    Time frame: Retrospective analysis from July 2021 to June 2025

  2. Time to the first occurrence of an inpatient hospitalisation with a primary diagnosis of heart failure

    Time frame: Retrospective analysis from July 2021 to June 2025

  3. Time to the first occurrence of an inpatient hospital or emergency department diagnosis of heart failure for participants without a history of heart failure

    Time frame: Retrospective analysis from July 2021 to June 2025

  4. Time to occurrence of specific Urine Albumin-Creatine Ratio (UACR) decline thresholds

    Time frame: Retrospective analysis from July 2021 to June 2025

  5. Time to the first occurrence of a hospitalisation or emergency department visit with a diagnosis code for hyperkalaemia

    Time frame: Retrospective analysis from July 2021 to June 2025

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

FIRST-2.5: Finerenone Research of Early Safety and Effectiveness, Part 2.5

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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