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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease
• Intervention / Treatment: Drug: Finerenone (Kerendia, BAY948862); Drug: Others except finerenone

• Study Type: Observational
• Enrollment (Estimated): 150000

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States, 07981
      • Bayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with CKD and T2D who are eligible for finerenone prescription after the approval of finerenone in the US. The study cohort will identify patients who initiate finerenone and a comparator group of individuals with CKD and T2D not using finerenone. All eligible adult individuals (aged ≥ 18 years) in the data source will be selected for the study cohort without sampling from the source population. There will be no restrictions of the study population based on sex, race, or ethnicity.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Finerenone (Kerendia, BAY948862); Follow clinical practice/administration.
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	Drug: Others except finerenone; Follow clinical practice/administration. The non-use finerenone treatment strategy will require individuals to be free of finerenone use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the first occurrence of composite cardiovascular outcome	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.	Retrospective analysis from July 2021 to June 2025

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: CKD; T2DM
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; finerenone
• Other Study ID Numbers: 22663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No