account_circleRecruiting
Chronic kidney disease, Type 2 diabetes mellitus,
Bayer Identifier:
21785
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
AllAge
18 - N/ATrial summary
Enrollment Goal
4500Trial Dates
June 2022 - January 2028Phase
Phase 4Could I Receive a placebo
NoProducts
Kerendia (Finerenone, BAY94-8862)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many Locations | Many Locations, Argentina |
Not yet recruiting | Many Locations | Many Locations, Belgium |
Not yet recruiting | Many Locations | Many Locations, Brazil |
Recruiting | Many Locations | Many Locations, China |
Not yet recruiting | Many Locations | Many Locations, Canada |
Recruiting | Many Locations | Many Locations, Denmark |
Recruiting | Many Locations | Many Locations, Germany |
Not yet recruiting | Many Locations | Many Locations, Mexico |
Recruiting | Many Locations | Many Locations, Netherlands |
Withdrawn | Many Locations | Many Locations, Russia |
Not yet recruiting | Many Locations | Many Locations, Saudi Arabia |
Not yet recruiting | Many Locations | Many Locations, Singapore |
Recruiting | Many Locations | Many Locations, Switzerland |
Not yet recruiting | Many Locations | Many Locations, Taiwan |
Withdrawn | Prolato Clinical Research | Houston, 77054, United States |
Active, not recruiting | AKDHC Medical Research Servies LLC | Phoenix, 85016, United States |
Active, not recruiting | Clinical Research Stategies Inc | Houston, 77090, United States |
Withdrawn | Washington Nephrology Associates | Alexandria, 22304, United States |
Active, not recruiting | Kidney Disease Medical Group | Glendale, 91206, United States |
Withdrawn | Northwest Louisiana Nephrology | Shreveport, 71101, United States |
Active, not recruiting | University of Central Florida College of Medicine | Orlando, 32817, United States |
Withdrawn | Ellipsis Group | Alpharetta, 30022, United States |
Withdrawn | Keck School of Medicine of University of Southern California | Los Angeles, 90033, United States |
Active, not recruiting | University of Maryland Midtown Professionals Group Healthcare | Baltimore, 21201, United States |
Active, not recruiting | Healthy Heart Cardiology | Grand Rapids, 49546, United States |
Withdrawn | Cook County Health | Chicago, 60612, United States |
Active, not recruiting | Medico | Chicago, 60616, United States |
Active, not recruiting | Nephrology Consultants LLC | Huntsville, 35805, United States |
Active, not recruiting | Herman Clinical Research LLC | Suwanee, 30024, United States |
Active, not recruiting | RGV Endocrine Center | McAllen, 78503, United States |
Active, not recruiting | Nephrology Associates Northern Illinois and Indiana | Hinsdale, 60521, United States |
Active, not recruiting | Tranquil Clinical Research | Webster, 77598, United States |
Active, not recruiting | AA Medical Research Center | Flint, 48504, United States |
Active, not recruiting | Renal Consultants Medical Group | Granada Hills, 91344, United States |
Active, not recruiting | Dallas Renal Group | Plano, 75093, United States |
Active, not recruiting | Academy of Diabetes Thyroid and Endocrine | El Paso, 79935, United States |
Active, not recruiting | Metabolic Research Institute | West Palm Beach, 33401, United States |
Withdrawn | University of Utah | Salt Lake City, 84108, United States |
Active, not recruiting | Nephrology and Hypertension Associates | Tupelo, 38801, United States |
Active, not recruiting | The EnLyv Clinics | Edison, 08820, United States |
Active, not recruiting | Coastal Medical Research | Brunswick, 31523, United States |
Active, not recruiting | MultiCare Endocrinology Specialists Tacoma | Tacoma, 98405, United States |
Active, not recruiting | Augusta University | Augusta, 30912, United States |
Withdrawn | Jackson Medical Mall University Home Dialysis Clinic | Jackson, 39213, United States |
Active, not recruiting | Caritas Medical Center | Stockbridge, 30281, United States |
Active, not recruiting | Harrisburg Family Medical Center | Harrisburg, 72432, United States |
Active, not recruiting | Ochsner Medical Foundation | Slidell, 70461, United States |
Withdrawn | Jesse Brown VA Medical Center | Chicago, 60612, United States |
Not yet recruiting | Many Locations | Many Locations, Thailand |
Not yet recruiting | Many Locations | Many Locations, Slovenia |
Active, not recruiting | Pacific Diabetes & Endocrine Center | Honolulu, 96813, United States |
Active, not recruiting | DarSalud Care / LifeDOC Research | Memphis, 38119, United States |
Withdrawn | University of Iowa Preventive Intervention Clinic | Iowa City, 52242, United States |
Withdrawn | UCSF Nephrology Clinic | San Francisco, 94143, United States |
Active, not recruiting | Kidney and Hypertension Center of Wabash Valley LLC | Terre Haute, 47804, United States |
Active, not recruiting | Gulf View Medical | Port Charlotte, 33952, United States |
Active, not recruiting | Ardmore Medical Research | Winston Salem, 27103, United States |
Not yet recruiting | Gaffney Health Services | Charlotte, 28205, United States |
Active, not recruiting | Bland Clinic | Greensboro, 27401, United States |
Not yet recruiting | Many Locations | Many Locations, South Korea |
Active, not recruiting | Renown Regional Medical Center | Reno, 89502, United States |
Active, not recruiting | Hanson Clinical Research Center | Port Charlotte, 33952, United States |
Active, not recruiting | Care Access Research – Minneapolis | Minneapolis, 55403, USA |
Active, not recruiting | Laurie Tom, MD | Honolulu, 96813, United States |
Active, not recruiting | Panoramic Health | Providence, 02904, United States |
Active, not recruiting | NECCR Primacare Research, LLC | Fall River, 02721, United States |
Recruiting | Many Locations | Many Locations, Greece |
Recruiting | Many Locations | Many 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 finerenonedate_rangeTime Frame:Approximately 62 months
- Planned and actual daily dose of finerenone treatmentdate_rangeTime Frame:Approximately 62 months
- Planned and actual frequency of finerenone treatmentdate_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 hyperkalemialeading to permanent study drug discontinuation, dialysis or hospitalizationdate_rangeTime Frame:Approximately 62 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A