account_circleRecruiting

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

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.

Trial summary

Enrollment Goal
4500
Trial Dates
June 2022 - January 2028
Phase
Phase 4
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many LocationsMany Locations, Argentina
Not yet recruiting
Many LocationsMany Locations, Belgium
Not yet recruiting
Many LocationsMany Locations, Brazil
Recruiting
Many LocationsMany Locations, China
Not yet recruiting
Many LocationsMany Locations, Canada
Recruiting
Many LocationsMany Locations, Denmark
Recruiting
Many LocationsMany Locations, Germany
Not yet recruiting
Many LocationsMany Locations, Mexico
Recruiting
Many LocationsMany Locations, Netherlands
Withdrawn
Many LocationsMany Locations, Russia
Not yet recruiting
Many LocationsMany Locations, Saudi Arabia
Not yet recruiting
Many LocationsMany Locations, Singapore
Recruiting
Many LocationsMany Locations, Switzerland
Not yet recruiting
Many LocationsMany Locations, Taiwan
Withdrawn
Prolato Clinical ResearchHouston, 77054, United States
Active, not recruiting
AKDHC Medical Research Servies LLCPhoenix, 85016, United States
Active, not recruiting
Clinical Research Stategies IncHouston, 77090, United States
Withdrawn
Washington Nephrology AssociatesAlexandria, 22304, United States
Active, not recruiting
Kidney Disease Medical GroupGlendale, 91206, United States
Withdrawn
Northwest Louisiana NephrologyShreveport, 71101, United States
Active, not recruiting
University of Central Florida College of MedicineOrlando, 32817, United States
Withdrawn
Ellipsis GroupAlpharetta, 30022, United States
Withdrawn
Keck School of Medicine of University of Southern CaliforniaLos Angeles, 90033, United States
Active, not recruiting
University of Maryland Midtown Professionals Group HealthcareBaltimore, 21201, United States
Active, not recruiting
Healthy Heart CardiologyGrand Rapids, 49546, United States
Withdrawn
Cook County HealthChicago, 60612, United States
Active, not recruiting
MedicoChicago, 60616, United States
Active, not recruiting
Nephrology Consultants LLCHuntsville, 35805, United States
Active, not recruiting
Herman Clinical Research LLCSuwanee, 30024, United States
Active, not recruiting
RGV Endocrine CenterMcAllen, 78503, United States
Active, not recruiting
Nephrology Associates Northern Illinois and IndianaHinsdale, 60521, United States
Active, not recruiting
Tranquil Clinical ResearchWebster, 77598, United States
Active, not recruiting
AA Medical Research CenterFlint, 48504, United States
Active, not recruiting
Renal Consultants Medical GroupGranada Hills, 91344, United States
Active, not recruiting
Dallas Renal GroupPlano, 75093, United States
Active, not recruiting
Academy of Diabetes Thyroid and EndocrineEl Paso, 79935, United States
Active, not recruiting
Metabolic Research InstituteWest Palm Beach, 33401, United States
Withdrawn
University of UtahSalt Lake City, 84108, United States
Active, not recruiting
Nephrology and Hypertension AssociatesTupelo, 38801, United States
Active, not recruiting
The EnLyv ClinicsEdison, 08820, United States
Active, not recruiting
Coastal Medical ResearchBrunswick, 31523, United States
Active, not recruiting
MultiCare Endocrinology Specialists TacomaTacoma, 98405, United States
Active, not recruiting
Augusta UniversityAugusta, 30912, United States
Withdrawn
Jackson Medical Mall University Home Dialysis ClinicJackson, 39213, United States
Active, not recruiting
Caritas Medical CenterStockbridge, 30281, United States
Active, not recruiting
Harrisburg Family Medical CenterHarrisburg, 72432, United States
Active, not recruiting
Ochsner Medical FoundationSlidell, 70461, United States
Withdrawn
Jesse Brown VA Medical CenterChicago, 60612, United States
Not yet recruiting
Many LocationsMany Locations, Thailand
Not yet recruiting
Many LocationsMany Locations, Slovenia
Active, not recruiting
Pacific Diabetes & Endocrine CenterHonolulu, 96813, United States
Active, not recruiting
DarSalud Care / LifeDOC ResearchMemphis, 38119, United States
Withdrawn
University of Iowa Preventive Intervention ClinicIowa City, 52242, United States
Withdrawn
UCSF Nephrology ClinicSan Francisco, 94143, United States
Active, not recruiting
Kidney and Hypertension Center of Wabash Valley LLCTerre Haute, 47804, United States
Active, not recruiting
Gulf View MedicalPort Charlotte, 33952, United States
Active, not recruiting
Ardmore Medical ResearchWinston Salem, 27103, United States
Not yet recruiting
Gaffney Health ServicesCharlotte, 28205, United States
Active, not recruiting
Bland ClinicGreensboro, 27401, United States
Not yet recruiting
Many LocationsMany Locations, South Korea
Active, not recruiting
Renown Regional Medical CenterReno, 89502, United States
Active, not recruiting
Hanson Clinical Research CenterPort Charlotte, 33952, United States
Active, not recruiting
Care Access Research – MinneapolisMinneapolis, 55403, USA
Active, not recruiting
Laurie Tom, MDHonolulu, 96813, United States
Active, not recruiting
Panoramic HealthProvidence, 02904, United States
Active, not recruiting
NECCR Primacare Research, LLCFall River, 02721, United States
Recruiting
Many LocationsMany Locations, Greece
Recruiting
Many LocationsMany Locations, Portugal

Primary Outcome

  • Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes(T2D).
    date_rangeTime Frame:
    Approximately 62 months
  • Descriptive summary of reasons for introducing finerenone.
    date_rangeTime Frame:
    Approximately 62 months
  • Descriptive summary of reasons for discontinuation of finerenone.
    date_rangeTime Frame:
    Approximately 62 months
  • Planned and actual duration of treatment with finerenone
    date_rangeTime Frame:
    Approximately 62 months
  • Planned and actual daily dose of finerenone treatment
    date_rangeTime Frame:
    Approximately 62 months
  • Planned and actual frequency of finerenone treatment
    date_rangeTime Frame:
    Approximately 62 months
  • Descriptive summary of secondary therapies used in participants with CKD and T2D.
    date_rangeTime Frame:
    Approximately 62 months

Secondary Outcome

  • Occurrence of adverse events (AEs) and serious adverse events (SAEs)
    date_rangeTime Frame:
    Approximately 62 months
  • Occurrence of hyperkalemia
    leading to permanent study drug discontinuation, dialysis or hospitalization
    date_rangeTime Frame:
    Approximately 62 months

Trial design

FINE-REAL: A non-interventional study providing insights into the use of finerenone in a routine clinical setting
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A