A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting
- Conditions
- Type 2 Diabetes MellitusChronic Kidney Disease
- Interventions
- Registration Number
- NCT05348733
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4500
- 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
- Participation in an investigational trial at any time during the course of this study
- Contra-indications according to the local label.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants diagnosed with CKD and T2D Kerendia (Finerenone, BAY94-8862) Participants who are newly prescribed finerenone under routine treatment conditions.
- Primary Outcome Measures
Name Time Method Planned and actual daily dose of finerenone treatment Approximately 62 months Descriptive summary of reasons for introducing finerenone. Approximately 62 months Planned and actual duration of treatment with finerenone Approximately 62 months Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes(T2D). 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 Descriptive summary of reasons for discontinuation of finerenone. Approximately 62 months
- Secondary Outcome Measures
Name Time Method Occurrence of adverse events (AEs) and serious adverse events (SAEs) Approximately 62 months Occurrence of hyperkalemia Approximately 62 months leading to permanent study drug discontinuation, dialysis or hospitalization
Trial Locations
- Locations (50)
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
Many Locations
🇹ðŸ‡Multiple Locations, Thailand