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
1 other identifier
observational
4,613
19 countries
56
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Longer than P75 for all trials
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 27, 2022
CompletedStudy Start
First participant enrolled
June 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2026
April 14, 2026
April 1, 2026
4.3 years
April 1, 2022
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (7)
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
Planned and actual daily dose of finerenone treatment
Approximately 62 months
Planned and actual frequency of finerenone treatment
Approximately 62 months
Descriptive summary of secondary therapies used in participants with CKD and T2D.
Approximately 62 months
Secondary Outcomes (2)
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Approximately 62 months
Occurrence of hyperkalemia
Approximately 62 months
Other Outcomes (2)
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
Study Arms (1)
Participants diagnosed with CKD and T2D
Participants who are newly prescribed finerenone under routine treatment conditions.
Interventions
Decision will taken by the treating physician to initiate treatment with finerenone.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Participation in an investigational trial at any time during the course of this study
- Contra-indications according to the local label.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (56)
Nephrology Consultants LLC
Huntsville, Alabama, 35805, United States
AKDHC Medical Research Servies LLC
Phoenix, Arizona, 85016, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, 72432, United States
Kidney Disease Medical Group
Glendale, California, 91206, United States
Renal Consultants Medical Group
Granada Hills, California, 91344, United States
University of Central Florida College of Medicine
Orlando, Florida, 32817, United States
Gulf View Medical
Port Charlotte, Florida, 33952, United States
Hanson Clinical Research Center
Port Charlotte, Florida, 33952, United States
Metabolic Research Institute
West Palm Beach, Florida, 33401, United States
Augusta University
Augusta, Georgia, 30912, United States
Coastal Medical Research
Brunswick, Georgia, 31523, United States
Caritas Medical Center
Stockbridge, Georgia, 30281, United States
Herman Clinical Research LLC
Suwanee, Georgia, 30024, United States
Laurie Tom, MD
Honolulu, Hawaii, 96813, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96813, United States
Medico
Chicago, Illinois, 60616, United States
Nephrology Associates Northern Illinois and Indiana
Hinsdale, Illinois, 60521, United States
Kidney and Hypertension Center of Wabash Valley LLC
Terre Haute, Indiana, 47804, United States
Ochsner Medical Foundation
Slidell, Louisiana, 70461, United States
University of Maryland Midtown Professionals Group Healthcare
Baltimore, Maryland, 21201, United States
NECCR Primacare Research, LLC
Fall River, Massachusetts, 02721, United States
Healthy Heart Cardiology
Grand Rapids, Michigan, 49546, United States
Care Access Research - Minneapolis
Minneapolis, Minnesota, 55403, United States
Nephrology and Hypertension Associates
Tupelo, Mississippi, 38801, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
The EnLyv Clinics
Edison, New Jersey, 08820, United States
Gaffney Health Services
Charlotte, North Carolina, 28205, United States
Bland Clinic
Greensboro, North Carolina, 27401, United States
Ardmore Medical Research
Winston-Salem, North Carolina, 27103, United States
Panoramic Health
Providence, Rhode Island, 02904, United States
DarSalud Care / LifeDOC Research
Memphis, Tennessee, 38119, United States
Academy of Diabetes Thyroid and Endocrine
El Paso, Texas, 79935, United States
AA Medical Research Center
Flint, Texas, 48504, United States
Clinical Research Stategies Inc
Houston, Texas, 77090, United States
RGV Endocrine Center
McAllen, Texas, 78503, United States
Dallas Renal Group
Plano, Texas, 75093, United States
Tranquil Clinical Research
Webster, Texas, 77598, United States
MultiCare Endocrinology Specialists Tacoma
Tacoma, Washington, 98405, United States
Many Locations
Multiple Locations, Argentina
Many Locations
Multiple Locations, Belgium
Many Locations
Multiple Locations, Brazil
Many Locations
Multiple Locations, Canada
Many Locations
Multiple Locations, China
Many Locations
Multiple Locations, Denmark
Many Locations
Multiple Locations, Germany
Many Locations
Multiple Locations, Greece
Many Locations
Multiple Locations, Mexico
Many Locations
Multiple Locations, Netherlands
Many Locations
Multiple Locations, Portugal
Many Locations
Multiple Locations, Saudi Arabia
Many Locations
Multiple Locations, Singapore
Many Locations
Multiple Locations, Slovenia
Many Locations
Multiple Locations, South Korea
Many Locations
Multiple Locations, Switzerland
Many Locations
Multiple Locations, Taiwan
Many Locations
Multiple Locations, Thailand
Related Publications (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. 2025 Nov 6. doi: 10.1681/ASN.0000000928. Online ahead of print.
PMID: 41196655DERIVEDDesai 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.
PMID: 36857997DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2022
First Posted
April 27, 2022
Study Start
June 13, 2022
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 15, 2026
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.