Clinical trial NCT05348733: A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting
Official title: FINE-REAL: A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease
Type 2 Diabetes Mellitus
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Participation in an investigational trial at any time during the course of this study
* Contra-indications according to the local label.

Primary outcomes:
measure: Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes(T2D).
timeFrame: Approximately 62 months
measure: Descriptive summary of reasons for introducing finerenone.
timeFrame: Approximately 62 months
measure: Descriptive summary of reasons for discontinuation of finerenone.
timeFrame: Approximately 62 months
measure: Planned and actual duration of treatment with finerenone
timeFrame: Approximately 62 months
measure: Planned and actual daily dose of finerenone treatment
timeFrame: Approximately 62 months
measure: Planned and actual frequency of finerenone treatment
timeFrame: Approximately 62 months
measure: Descriptive summary of secondary therapies used in participants with CKD and T2D.
timeFrame: Approximately 62 months
Secondary outcomes:
measure: Occurrence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Approximately 62 months
measure: Occurrence of hyperkalemia
timeFrame: Approximately 62 months
Other outcomes:
measure: Descriptive summary for healthcare resource utilization.
timeFrame: Approximately 62 months
measure: Occurrence of newly diagnosed diabetic retinopathy or progression of existing disease at treatment initiation
timeFrame: Approximately 62 months
Locations:
city: Huntsville
country: United States
facility: Nephrology Consultants LLC
state: Alabama
city: Phoenix
country: United States
facility: AKDHC Medical Research Servies LLC
state: Arizona
city: Harrisburg
country: United States
facility: Harrisburg Family Medical Center
state: Arkansas
city: Glendale
country: United States
facility: Kidney Disease Medical Group
state: California
city: Granada Hills
country: United States
facility: Renal Consultants Medical Group
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine of University of Southern California
state: California
city: San Francisco
country: United States
facility: UCSF Nephrology Clinic
state: California
city: Orlando
country: United States
facility: University of Central Florida College of Medicine
state: Florida
city: Port Charlotte
country: United States
facility: Gulf View Medical
state: Florida
city: Port Charlotte
country: United States
facility: Hanson Clinical Research Center
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute
state: Florida
city: Alpharetta
country: United States
facility: Ellipsis Group
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Brunswick
country: United States
facility: Coastal Medical Research
state: Georgia
city: Stockbridge
country: United States
facility: Caritas Medical Center
state: Georgia
city: Suwanee
country: United States
facility: Herman Clinical Research LLC
state: Georgia
city: Honolulu
country: United States
facility: Laurie Tom, MD
state: Hawaii
city: Honolulu
country: United States
facility: Pacific Diabetes & Endocrine Center
state: Hawaii
city: Chicago
country: United States
facility: Cook County Health
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Chicago
country: United States
facility: Medico
state: Illinois
city: Hinsdale
country: United States
facility: Nephrology Associates Northern Illinois and Indiana
state: Illinois
city: Terre Haute
country: United States
facility: Kidney and Hypertension Center of Wabash Valley LLC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Preventive Intervention Clinic
state: Iowa
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology
state: Louisiana
city: Slidell
country: United States
facility: Ochsner Medical Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Midtown Professionals Group Healthcare
state: Maryland
city: Fall River
country: United States
facility: NECCR Primacare Research, LLC
state: Massachusetts
city: Grand Rapids
country: United States
facility: Healthy Heart Cardiology
state: Michigan
city: Minneapolis
country: United States
facility: Care Access Research - Minneapolis
state: Minnesota
city: Jackson
country: United States
facility: Jackson Medical Mall University Home Dialysis Clinic
state: Mississippi
city: Tupelo
country: United States
facility: Nephrology and Hypertension Associates
state: Mississippi
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Edison
country: United States
facility: The EnLyv Clinics
state: New Jersey
city: Charlotte
country: United States
facility: Gaffney Health Services
state: North Carolina
city: Greensboro
country: United States
facility: Bland Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: Ardmore Medical Research
state: North Carolina
city: Providence
country: United States
facility: Panoramic Health
state: Rhode Island
city: Memphis
country: United States
facility: DarSalud Care / LifeDOC Research
state: Tennessee
city: El Paso
country: United States
facility: Academy of Diabetes Thyroid and Endocrine
state: Texas
city: Flint
country: United States
facility: AA Medical Research Center
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research
state: Texas
city: Houston
country: United States
facility: Clinical Research Stategies Inc
state: Texas
city: McAllen
country: United States
facility: RGV Endocrine Center
state: Texas
city: Plano
country: United States
facility: Dallas Renal Group
state: Texas
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Alexandria
country: United States
facility: Washington Nephrology Associates
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Endocrinology Specialists Tacoma
state: Washington
city: Multiple Locations
country: Argentina
facility: Many Locations
city: Multiple Locations
country: Belgium
facility: Many Locations
city: Multiple Locations
country: Brazil
facility: Many Locations
city: Multiple Locations
country: Canada
facility: Many Locations
city: Multiple Locations
country: China
facility: Many Locations
city: Multiple Locations
country: Denmark
facility: Many Locations
city: Multiple Locations
country: Germany
facility: Many Locations
city: Multiple Locations
country: Greece
facility: Many Locations
city: Multiple Locations
country: Korea, Republic of
facility: Many Locations
city: Multiple Locations
country: Mexico
facility: Many Locations
city: Multiple Locations
country: Netherlands
facility: Many Locations
city: Multiple Locations
country: Portugal
facility: Many Locations
city: Multiple Locations
country: Russian Federation
facility: Many Locations
city: Multiple Locations
country: Saudi Arabia
facility: Many Locations
city: Multiple Locations
country: Singapore
facility: Many Locations
city: Multiple Locations
country: Slovenia
facility: Many Locations
city: Multiple Locations
country: Switzerland
facility: Many Locations
city: Multiple Locations
country: Taiwan
facility: Many Locations
city: Multiple Locations
country: Thailand
facility: Many Locations
Study officials:
References: