Trial Condition(s):

Chronic Kidney Disease, Type 2 Diabetes Mellitus

A study called FINE-REAL to learn more about the use of the drug finerenone in a routine medical care setting

Bayer Identifier:

21785

ClinicalTrials.gov Identifier:

NCT05348733

EudraCT Number:

Not Available

Recruiting

Trial Purpose

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.

Inclusion Criteria
- Adult female or male patient (≥18 years old)
 - Diagnosis of CKD associated with T2D based on assessment by physician.
 - Treatment initiation with finerenone was made as per local label.
 - 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.

Trial Summary

Enrollment Goal
5500
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Belgium

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Brazil

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Not yet recruiting
 
Locations

Many Locations

Many Locations, China

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Canada

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Colombia

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Denmark

Status
Recruiting
 
Locations

Many Locations

Many Locations, Germany

Status
Recruiting
 
Locations

Many Locations

Many Locations, Luxembourg

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Mexico

Status
Recruiting
 
Locations

Many Locations

Many Locations, Netherlands

Status
Recruiting
 
Locations

Many Locations

Many Locations, France

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Italy

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Saudi Arabia

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Singapore

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Spain

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Switzerland

Status
Recruiting
 
Locations

Many Locations

Many Locations, Taiwan, China

Status
Not yet recruiting
 
Locations

Prolato Clinical Research

Houston, United States, 77054

Status
Not yet recruiting
 
Locations

AKDHC Medical Research Servies LLC

Phoenix, United States, 85016

Status
Recruiting
 
Locations

Clinical Research Stategies Inc

Houston, United States, 77090

Status
Recruiting
 
Locations

Kidney Disease Medical Group

Glendale, United States, 91206

Status
Recruiting
 
Locations

University of Central Florida College of Medicine

Orlando, United States, 32817

Status
Recruiting
 
Locations

Ellipsis Group

Alpharetta, United States, 30022

Status
Recruiting
 
Locations

Keck School of Medicine of University of Southern California

Los Angeles, United States, 90033

Status
Not yet recruiting
 
Locations

University of Maryland Midtown Professionals Group Healthcare

Baltimore, United States, 21201

Status
Recruiting
 
Locations

Healthy Heart Cardiology

Grand Rapids, United States, 49546

Status
Recruiting
 
Locations

Cook County Health

Chicago, United States, 60612

Status
Not yet recruiting
 
Locations

Medico

Chicago, United States, 60616

Status
Recruiting
 
Locations

Nephrology Consultants LLC

Huntsville, United States, 35805

Status
Recruiting
 
Locations

Herman Clinical Research LLC

Suwanee, United States, 30024

Status
Recruiting
 
Locations

RGV Endocrine Center

McAllen, United States, 78503

Status
Recruiting
 
Locations

Nephrology Associates Northern Illinois and Indiana

Hinsdale, United States, 60521

Status
Recruiting
 
Locations

Tranquil Clinical Research

Webster, United States, 77598

Status
Recruiting
 
Locations

AA Medical Research Center

Flint, United States, 48504

Status
Recruiting
 
Locations

Renal Consultants Medical Group

Granada Hills, United States, 91344

Status
Recruiting
 
Locations

Dallas Renal Group

Plano, United States, 75093

Status
Recruiting
 
Locations

Academy of Diabetes Thyroid and Endocrine

El Paso, United States, 79935

Status
Recruiting
 
Locations

Metabolic Research Institute

West Palm Beach, United States, 33401

Status
Recruiting
 
Locations

University of Utah

Salt Lake City, United States, 84108

Status
Not yet recruiting
 
Locations

Nephrology and Hypertension Associates

Tupelo, United States, 38801

Status
Recruiting
 
Locations

The EnLyv Clinics

Edison, United States, 08820

Status
Recruiting
 
Locations

Coastal Medical Research

Brunswick, United States, 31523

Status
Recruiting
 
Locations

MultiCare Endocrinology Specialists Tacoma

Tacoma, United States, 98405

Status
Recruiting
 
Locations

Augusta University

Augusta, United States, 30912

Status
Not yet recruiting
 
Locations

Jackson Medical Mall University Home Dialysis Clinic

Jackson, United States, 39213

Status
Not yet recruiting
 
Locations

Caritas Medical Center

Stockbridge, United States, 30281

Status
Recruiting
 
Locations

Harrisburg Family Medical Center

Harrisburg, United States, 72432

Status
Recruiting
 
Locations

Ochsner Medical Foundation

Slidell, United States, 70461

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Thailand

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Slovenia

Status
Not yet recruiting
 
Locations

Pacific Diabetes & Endocrine Center

Honolulu, United States, 96813

Status
Recruiting
 
Locations

DarSalud Care / LifeDOC Research

Memphis, United States, 38119

Status
Not yet recruiting
 
Locations

Kidney and Hypertension Center of Wabash Valley LLC

Terre Haute, United States, 47804

Status
Not yet recruiting
 
Locations

Gulf View Medical

Port Charlotte, United States, 33952

Status
Not yet recruiting
 
Locations

Ardmore Medical Research

Winston Salem, United States, 27103

Status
Recruiting
 
Locations

Gaffney Health Services

Charlotte, United States, 28205

Status
Not yet recruiting
 
Locations

Bland Clinic

Greensboro, United States, 27401

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Chile

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, South Korea

Status
Not yet recruiting
 
Locations

Renown Health

Reno, United States, 89502

Status
Not yet recruiting
 
Locations

Hanson Diabetes

Port Charlotte, United States, 33952

Status
Not yet recruiting
 

Trial Design