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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348733
• Other study ID #: 21785
• Status: Recruiting
• Start date: June 13, 2022
• Est. completion date: January 1, 2028

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5500
• Est. completion date: January 1, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult female or male patient (=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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Kerendia (Finerenone, BAY94-8862)
Decision will taken by the treating physician to initiate treatment with finerenone.

Locations

Country	Name	City	State
Argentina	Many Locations	Multiple Locations
Belgium	Many Locations	Multiple Locations
Brazil	Many Locations	Multiple Locations
Canada	Many Locations	Multiple Locations
Chile	Many Locations	Multiple Locations
China	Many Locations	Multiple Locations
Colombia	Many Locations	Multiple Locations
Denmark	Many Locations	Multiple Locations
France	Many Locations	Multiple Locations
Germany	Many Locations	Multiple Locations
Italy	Many Locations	Multiple Locations
Korea, Republic of	Many Locations	Multiple Locations
Luxembourg	Many Locations	Multiple Locations
Mexico	Many Locations	Multiple Locations
Netherlands	Many Locations	Multiple Locations
Russian Federation	Many Locations	Multiple Locations
Saudi Arabia	Many Locations	Multiple Locations
Singapore	Many Locations	Multiple Locations
Slovenia	Many Locations	Multiple Locations
Spain	Many Locations	Multiple Locations
Switzerland	Many Locations	Multiple Locations
Taiwan	Many Locations	Multiple Locations
Thailand	Many Locations	Multiple Locations
United States	Washington Nephrology Associates	Alexandria	Virginia
United States	Ellipsis Group	Alpharetta	Georgia
United States	Augusta University	Augusta	Georgia
United States	University of Maryland Midtown Professionals Group Healthcare	Baltimore	Maryland
United States	Coastal Medical Research	Brunswick	Georgia
United States	Gaffney Health Services	Charlotte	North Carolina
United States	Cook County Health	Chicago	Illinois
United States	Jesse Brown VA Medical Center	Chicago	Illinois
United States	Medico	Chicago	Illinois
United States	The EnLyv Clinics	Edison	New Jersey
United States	Academy of Diabetes Thyroid and Endocrine	El Paso	Texas
United States	NECCR Primacare Research, LLC	Fall River	Massachusetts
United States	AA Medical Research Center	Flint	Texas
United States	Kidney Disease Medical Group	Glendale	California
United States	Renal Consultants Medical Group	Granada Hills	California
United States	Healthy Heart Cardiology	Grand Rapids	Michigan
United States	Bland Clinic	Greensboro	North Carolina
United States	Harrisburg Family Medical Center	Harrisburg	Arkansas
United States	Nephrology Associates Northern Illinois and Indiana	Hinsdale	Illinois
United States	Laurie Tom, MD	Honolulu	Hawaii
United States	Pacific Diabetes & Endocrine Center	Honolulu	Hawaii
United States	Clinical Research Stategies Inc	Houston	Texas
United States	Prolato Clinical Research	Houston	Texas
United States	Nephrology Consultants LLC	Huntsville	Alabama
United States	University of Iowa Preventive Intervention Clinic	Iowa City	Iowa
United States	Jackson Medical Mall University Home Dialysis Clinic	Jackson	Mississippi
United States	Keck School of Medicine of University of Southern California	Los Angeles	California
United States	RGV Endocrine Center	McAllen	Texas
United States	DarSalud Care / LifeDOC Research	Memphis	Tennessee
United States	Care Access Research - Minneapolis	Minneapolis	Minnesota
United States	University of Central Florida College of Medicine	Orlando	Florida
United States	AKDHC Medical Research Servies LLC	Phoenix	Arizona
United States	Dallas Renal Group	Plano	Texas
United States	Gulf View Medical	Port Charlotte	Florida
United States	Hanson Clinical Research Center	Port Charlotte	Florida
United States	Panoramic Health	Providence	Rhode Island
United States	Renown Regional Medical Center	Reno	Nevada
United States	University of Utah	Salt Lake City	Utah
United States	UCSF Nephrology Clinic	San Francisco	California
United States	Northwest Louisiana Nephrology	Shreveport	Louisiana
United States	Ochsner Medical Foundation	Slidell	Louisiana
United States	Caritas Medical Center	Stockbridge	Georgia
United States	Herman Clinical Research LLC	Suwanee	Georgia
United States	MultiCare Endocrinology Specialists Tacoma	Tacoma	Washington
United States	Kidney and Hypertension Center of Wabash Valley LLC	Terre Haute	Indiana
United States	Nephrology and Hypertension Associates	Tupelo	Mississippi
United States	Tranquil Clinical Research	Webster	Texas
United States	Metabolic Research Institute	West Palm Beach	Florida
United States	Ardmore Medical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  Denmark,  France,  Germany,  Italy,  Korea, Republic of,  Luxembourg,  Mexico,  Netherlands,  Russian Federation,  Saudi Arabia,  Singapore,  Slovenia,  Spain,  Switzerland,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Descriptive summary for healthcare resource utilization.		Approximately 62 months
Other	Occurrence of newly diagnosed diabetic retinopathy or progression of existing disease at treatment initiation		Approximately 62 months
Primary	Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes(T2D).		Approximately 62 months
Primary	Descriptive summary of reasons for introducing finerenone.		Approximately 62 months
Primary	Descriptive summary of reasons for discontinuation of finerenone.		Approximately 62 months
Primary	Planned and actual duration of treatment with finerenone		Approximately 62 months
Primary	Planned and actual daily dose of finerenone treatment		Approximately 62 months
Primary	Planned and actual frequency of finerenone treatment		Approximately 62 months
Primary	Descriptive summary of secondary therapies used in participants with CKD and T2D.		Approximately 62 months
Secondary	Occurrence of adverse events (AEs) and serious adverse events (SAEs)		Approximately 62 months
Secondary	Occurrence of hyperkalemia	leading to permanent study drug discontinuation, dialysis or hospitalization	Approximately 62 months

External Links

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