A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting
NCT ID: NCT05348733
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4500 participants
OBSERVATIONAL
2022-06-13
2026-12-15
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants diagnosed with CKD and T2D
Participants who are newly prescribed finerenone under routine treatment conditions.
Kerendia (Finerenone, BAY94-8862)
Decision will taken by the treating physician to initiate treatment with finerenone.
Interventions
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Kerendia (Finerenone, BAY94-8862)
Decision will taken by the treating physician to initiate treatment with finerenone.
Eligibility Criteria
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Inclusion Criteria
* 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
* Contra-indications according to the local label.
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Nephrology Consultants LLC
Huntsville, Alabama, United States
AKDHC Medical Research Servies LLC
Phoenix, Arizona, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States
Kidney Disease Medical Group
Glendale, California, United States
Renal Consultants Medical Group
Granada Hills, California, United States
Keck School of Medicine of University of Southern California
Los Angeles, California, United States
UCSF Nephrology Clinic
San Francisco, California, United States
University of Central Florida College of Medicine
Orlando, Florida, United States
Gulf View Medical
Port Charlotte, Florida, United States
Hanson Clinical Research Center
Port Charlotte, Florida, United States
Metabolic Research Institute
West Palm Beach, Florida, United States
Ellipsis Group
Alpharetta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Coastal Medical Research
Brunswick, Georgia, United States
Caritas Medical Center
Stockbridge, Georgia, United States
Herman Clinical Research LLC
Suwanee, Georgia, United States
Laurie Tom, MD
Honolulu, Hawaii, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States
Cook County Health
Chicago, Illinois, United States
Jesse Brown VA Medical Center
Chicago, Illinois, United States
Medico
Chicago, Illinois, United States
Nephrology Associates Northern Illinois and Indiana
Hinsdale, Illinois, United States
Kidney and Hypertension Center of Wabash Valley LLC
Terre Haute, Indiana, United States
University of Iowa Preventive Intervention Clinic
Iowa City, Iowa, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States
Ochsner Medical Foundation
Slidell, Louisiana, United States
University of Maryland Midtown Professionals Group Healthcare
Baltimore, Maryland, United States
NECCR Primacare Research, LLC
Fall River, Massachusetts, United States
Healthy Heart Cardiology
Grand Rapids, Michigan, United States
Care Access Research - Minneapolis
Minneapolis, Minnesota, United States
Jackson Medical Mall University Home Dialysis Clinic
Jackson, Mississippi, United States
Nephrology and Hypertension Associates
Tupelo, Mississippi, United States
Renown Regional Medical Center
Reno, Nevada, United States
The EnLyv Clinics
Edison, New Jersey, United States
Gaffney Health Services
Charlotte, North Carolina, United States
Bland Clinic
Greensboro, North Carolina, United States
Ardmore Medical Research
Winston-Salem, North Carolina, United States
Panoramic Health
Providence, Rhode Island, United States
DarSalud Care / LifeDOC Research
Memphis, Tennessee, United States
Academy of Diabetes Thyroid and Endocrine
El Paso, Texas, United States
AA Medical Research Center
Flint, Texas, United States
Prolato Clinical Research
Houston, Texas, United States
Clinical Research Stategies Inc
Houston, Texas, United States
RGV Endocrine Center
McAllen, Texas, United States
Dallas Renal Group
Plano, Texas, United States
Tranquil Clinical Research
Webster, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Washington Nephrology Associates
Alexandria, Virginia, United States
MultiCare Endocrinology Specialists Tacoma
Tacoma, Washington, United States
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Countries
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Central Contacts
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References
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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.
Related Links
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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.
Other Identifiers
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21785
Identifier Type: -
Identifier Source: org_study_id