A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting

FINE-REAL: A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting

This is an observational study in people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone.

Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D.

Finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse.

Finerenone is available and approved for doctors to prescribe to people with CKD and T2D. Since it has only recently become available for these patients, there is a need for more information about the use of finerenone in the real-world setting.

The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who just started or will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care.

To answer this question, the researchers will collect data on:

• Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants
• Reasons for starting finerenone
• Reasons for stopping finerenone early
• How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken)
• Dosing of finerenone
• Other medications used while taking finerenone

The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment.

Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to:

• Stopping finerenone treatment too early
• Dialysis (a medical procedure to filter the blood of extra water and waste)
• Care in a hospital

All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care.

Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time.

Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in September 2027.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease
• Intervention / Treatment: Drug: Kerendia (Finerenone, BAY94-8862)

• Study Type: Observational
• Enrollment (Actual): 4613

Contacts and Locations

Study Locations

• Argentina
  • Multiple Locations, Argentina
    • Many locations
• Belgium
  • Multiple Locations, Belgium
    • Many locations
• Brazil
  • Multiple Locations, Brazil
    • Many locations
• Canada
  • Multiple Locations, Canada
    • Many locations
• China
  • Multiple Locations, China
    • Many locations
• Denmark
  • Multiple Locations, Denmark
    • Many locations
• Germany
  • Multiple Locations, Germany
    • Many locations
• Greece
  • Multiple Locations, Greece
    • Many locations
• Mexico
  • Multiple Locations, Mexico
    • Many locations
• Netherlands
  • Multiple Locations, Netherlands
    • Many locations
• Portugal
  • Multiple Locations, Portugal
    • Many locations
• Saudi Arabia
  • Multiple Locations, Saudi Arabia
    • Many locations
• Singapore
  • Multiple Locations, Singapore
    • Many locations
• Slovenia
  • Multiple Locations, Slovenia
    • Many locations
• South Korea
  • Multiple Locations, South Korea
    • Many locations
• Switzerland
  • Multiple Locations, Switzerland
    • Many locations
• Taiwan
  • Multiple Locations, Taiwan
    • Many locations
• Thailand
  • Multiple Locations, Thailand
    • Many locations
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Nephrology Consultants LLC
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • AKDHC Medical Research Servies LLC
  • Arkansas
    • Harrisburg, Arkansas, United States, 72432
      • Harrisburg Family Medical Center
  • California
    • Glendale, California, United States, 91206
      • Kidney Disease Medical Group
    • Granada Hills, California, United States, 91344
      • Renal Consultants Medical Group
  • Florida
    • Orlando, Florida, United States, 32817
      • University of Central Florida College of Medicine
    • Port Charlotte, Florida, United States, 33952
      • Hanson Clinical Research Center
    • Port Charlotte, Florida, United States, 33952
      • Gulf View Medical
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Brunswick, Georgia, United States, 31523
      • Coastal Medical Research
    • Stockbridge, Georgia, United States, 30281
      • Caritas Medical Center
    • Suwanee, Georgia, United States, 30024
      • Herman Clinical Research LLC
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Pacific Diabetes & Endocrine Center
    • Honolulu, Hawaii, United States, 96813
      • Laurie Tom, MD
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Medico
    • Hinsdale, Illinois, United States, 60521
      • Nephrology Associates Northern Illinois and Indiana
  • Indiana
    • Terre Haute, Indiana, United States, 47804
      • Kidney and Hypertension Center of Wabash Valley LLC
  • Louisiana
    • Slidell, Louisiana, United States, 70461
      • Ochsner Medical Foundation
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Midtown Professionals Group Healthcare
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • NECCR Primacare Research, LLC
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Healthy Heart Cardiology
  • Minnesota
    • Minneapolis, Minnesota, United States, 55403
      • Care Access Research - Minneapolis
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Nephrology and Hypertension Associates
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • The EnLyv Clinics
  • North Carolina
    • Charlotte, North Carolina, United States, 28205
      • Gaffney Health Services
    • Greensboro, North Carolina, United States, 27401
      • Bland Clinic
    • Winston-Salem, North Carolina, United States, 27103
      • Ardmore Medical Research
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Panoramic Health
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • DarSalud Care / LifeDOC Research
  • Texas
    • El Paso, Texas, United States, 79935
      • Academy of Diabetes Thyroid and Endocrine
    • Flint, Texas, United States, 48504
      • AA Medical Research Center
    • Houston, Texas, United States, 77090
      • Clinical Research Stategies Inc
    • McAllen, Texas, United States, 78503
      • RGV Endocrine Center
    • Plano, Texas, United States, 75093
      • Dallas Renal Group
    • Webster, Texas, United States, 77598
      • Tranquil Clinical Research
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Endocrinology Specialists Tacoma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with a diagnosed of CKD and T2D will be enrolled after the decision for treatment with finerenone has been made by the treating physician.

Description

Inclusion Criteria:

• Adult participants of all genders (≥18 years old)
• Diagnosis of CKD associated with T2D based on assessment by physician.
• Treatment according to local marketing authorization, finerenone 20 or 10 mg.Treatment should have been started up to 8 weeks before or after the ICF is signed.
• Decision to initiate treatment with finerenone must be made before ICF is signed.
• Signed informed consent

Exclusion Criteria:

• Participation in an investigational trial at any time during the course of this study
• Contra-indications according to the local label.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants diagnosed with CKD and T2D; Participants who are newly prescribed finerenone under routine treatment conditions.	Drug: Kerendia (Finerenone, BAY94-8862); Decision will taken by the treating physician to initiate treatment with finerenone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes(T2D).	Approximately 62 months
Descriptive summary of reasons for introducing finerenone.	Approximately 62 months
Descriptive summary of reasons for discontinuation of finerenone.	Approximately 62 months
Planned and actual duration of treatment with finerenone	Approximately 62 months
Descriptive summary of secondary therapies used in participants with CKD and T2D.	Approximately 62 months
Planned and actual daily dose of finerenone treatment	Approximately 62 months
Planned and actual frequency of finerenone treatment	Approximately 62 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events (AEs) and serious adverse events (SAEs)		Approximately 62 months
Occurrence of hyperkalemia	leading to permanent study drug discontinuation, dialysis or hospitalization	Approximately 62 months

Other Outcome Measures

Outcome Measure	Time Frame
Descriptive summary for healthcare resource utilization.	Approximately 62 months
Occurrence of newly diagnosed diabetic retinopathy or progression of existing disease at treatment initiation	Approximately 62 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Desai NR, Navaneethan SD, Nicholas SB, Pantalone KM, Wanner C, Hamacher S, Gay A, Wheeler DC. Design and rationale of FINE-REAL: A prospective study of finerenone in clinical practice. J Diabetes Complications. 2023 Apr;37(4):108411. doi: 10.1016/j.jdiacomp.2023.108411. Epub 2023 Feb 2.
• Mottl A, Scott C, Green JB, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Vaduganathan M, Agarwal R; CONFIDENCE Trial Investigators. Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial. J Am Soc Nephrol. 2026 Apr 1;37(4):764-776. doi: 10.1681/ASN.0000000928. Epub 2025 Nov 6.

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• 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: 21785

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