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

Status: Recruiting
Location: See all (68) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Nephrology Consultants LLC
ACTIVE_NOT_RECRUITING
Huntsville
Arkansas
Harrisburg Family Medical Center
ACTIVE_NOT_RECRUITING
Harrisburg
Arizona
AKDHC Medical Research Servies LLC
ACTIVE_NOT_RECRUITING
Phoenix
California
Kidney Disease Medical Group
ACTIVE_NOT_RECRUITING
Glendale
Renal Consultants Medical Group
ACTIVE_NOT_RECRUITING
Granada Hills
Keck School of Medicine of University of Southern California
WITHDRAWN
Los Angeles
UCSF Nephrology Clinic
WITHDRAWN
San Francisco
Florida
University of Central Florida College of Medicine
ACTIVE_NOT_RECRUITING
Orlando
Gulf View Medical
ACTIVE_NOT_RECRUITING
Port Charlotte
Hanson Clinical Research Center
ACTIVE_NOT_RECRUITING
Port Charlotte
Metabolic Research Institute
ACTIVE_NOT_RECRUITING
West Palm Beach
Georgia
Ellipsis Group
WITHDRAWN
Alpharetta
Augusta University
ACTIVE_NOT_RECRUITING
Augusta
Coastal Medical Research
ACTIVE_NOT_RECRUITING
Brunswick
Caritas Medical Center
ACTIVE_NOT_RECRUITING
Stockbridge
Herman Clinical Research LLC
ACTIVE_NOT_RECRUITING
Suwanee
Hawaii
Laurie Tom, MD
ACTIVE_NOT_RECRUITING
Honolulu
Pacific Diabetes & Endocrine Center
ACTIVE_NOT_RECRUITING
Honolulu
Iowa
University of Iowa Preventive Intervention Clinic
WITHDRAWN
Iowa City
Illinois
Cook County Health
WITHDRAWN
Chicago
Jesse Brown VA Medical Center
WITHDRAWN
Chicago
Medico
ACTIVE_NOT_RECRUITING
Chicago
Nephrology Associates Northern Illinois and Indiana
ACTIVE_NOT_RECRUITING
Hinsdale
Indiana
Kidney and Hypertension Center of Wabash Valley LLC
ACTIVE_NOT_RECRUITING
Terre Haute
Louisiana
Northwest Louisiana Nephrology
WITHDRAWN
Shreveport
Ochsner Medical Foundation
ACTIVE_NOT_RECRUITING
Slidell
Massachusetts
NECCR Primacare Research, LLC
ACTIVE_NOT_RECRUITING
Fall River
Maryland
University of Maryland Midtown Professionals Group Healthcare
ACTIVE_NOT_RECRUITING
Baltimore
Michigan
Healthy Heart Cardiology
ACTIVE_NOT_RECRUITING
Grand Rapids
Minnesota
Care Access Research - Minneapolis
ACTIVE_NOT_RECRUITING
Minneapolis
Mississippi
Jackson Medical Mall University Home Dialysis Clinic
WITHDRAWN
Jackson
Nephrology and Hypertension Associates
ACTIVE_NOT_RECRUITING
Tupelo
North Carolina
Gaffney Health Services
NOT_YET_RECRUITING
Charlotte
Bland Clinic
ACTIVE_NOT_RECRUITING
Greensboro
Ardmore Medical Research
ACTIVE_NOT_RECRUITING
Winston-salem
New Jersey
The EnLyv Clinics
ACTIVE_NOT_RECRUITING
Edison
Nevada
Renown Regional Medical Center
ACTIVE_NOT_RECRUITING
Reno
Rhode Island
Panoramic Health
ACTIVE_NOT_RECRUITING
Providence
Tennessee
DarSalud Care / LifeDOC Research
ACTIVE_NOT_RECRUITING
Memphis
Texas
Academy of Diabetes Thyroid and Endocrine
ACTIVE_NOT_RECRUITING
El Paso
AA Medical Research Center
ACTIVE_NOT_RECRUITING
Flint
Clinical Research Stategies Inc
ACTIVE_NOT_RECRUITING
Houston
Prolato Clinical Research
WITHDRAWN
Houston
RGV Endocrine Center
ACTIVE_NOT_RECRUITING
Mcallen
Dallas Renal Group
ACTIVE_NOT_RECRUITING
Plano
Tranquil Clinical Research
ACTIVE_NOT_RECRUITING
Webster
Utah
University of Utah
WITHDRAWN
Salt Lake City
Virginia
Washington Nephrology Associates
WITHDRAWN
Alexandria
Washington
MultiCare Endocrinology Specialists Tacoma
ACTIVE_NOT_RECRUITING
Tacoma
Other Locations
Argentina
Many Locations
RECRUITING
Multiple Locations
Belgium
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Brazil
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Canada
Many Locations
NOT_YET_RECRUITING
Multiple Locations
China
Many Locations
RECRUITING
Multiple Locations
Denmark
Many Locations
RECRUITING
Multiple Locations
Germany
Many Locations
RECRUITING
Multiple Locations
Greece
Many Locations
RECRUITING
Multiple Locations
Mexico
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Netherlands
Many Locations
RECRUITING
Multiple Locations
Portugal
Many Locations
RECRUITING
Multiple Locations
Republic of Korea
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Russian Federation
Many Locations
WITHDRAWN
Multiple Locations
Saudi Arabia
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Singapore
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Slovenia
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Switzerland
Many Locations
RECRUITING
Multiple Locations
Taiwan
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Thailand
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Contact Information
Primary
Bayer Clinical Trials Contact
clinical-trials-contact@bayer.com
(+)1-888-84 22937
Time Frame
Start Date: 2022-06-13
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 4500
Treatments
Participants diagnosed with CKD and T2D
Participants who are newly prescribed finerenone under routine treatment conditions.
Related Therapeutic Areas
Sponsors
Leads: Bayer

This content was sourced from clinicaltrials.gov