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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants diagnosed with CKD and T2D | Participants who are newly prescribed finerenone under routine treatment conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kerendia (Finerenone, BAY94-8862) | Drug | Decision will taken by the treating physician to initiate treatment with finerenone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes(T2D). | Approximately 62 months | |
| Descriptive summary of reasons for introducing finerenone. | Approximately 62 months | |
| Descriptive summary of reasons for discontinuation of finerenone. | Approximately 62 months | |
| Planned and actual duration of treatment with finerenone | Approximately 62 months | |
| Planned and actual daily dose of finerenone treatment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events (AEs) and serious adverse events (SAEs) | Approximately 62 months | |
| Occurrence of hyperkalemia | leading to permanent study drug discontinuation, dialysis or hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive summary for healthcare resource utilization. | Approximately 62 months | |
| Occurrence of newly diagnosed diabetic retinopathy or progression of existing disease at treatment initiation | Approximately 62 months |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Consultants LLC | Huntsville | Alabama | 35805 | United States | ||
| AKDHC Medical Research Servies LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41196655 | Derived | Mottl A, Scott C, Green JB, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Vaduganathan M, Agarwal R; CONFIDENCE Trial Investigators. Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial. J Am Soc Nephrol. 2026 Apr 1;37(4):764-776. doi: 10.1681/ASN.0000000928. Epub 2025 Nov 6. | |
| 36857997 |
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Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| Approximately 62 months |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Harrisburg Family Medical Center | Harrisburg | Arkansas | 72432 | United States |
| Kidney Disease Medical Group | Glendale | California | 91206 | United States |
| Renal Consultants Medical Group | Granada Hills | California | 91344 | United States |
| University of Central Florida College of Medicine | Orlando | Florida | 32817 | United States |
| Gulf View Medical | Port Charlotte | Florida | 33952 | United States |
| Hanson Clinical Research Center | Port Charlotte | Florida | 33952 | United States |
| Metabolic Research Institute | West Palm Beach | Florida | 33401 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| Coastal Medical Research | Brunswick | Georgia | 31523 | United States |
| Caritas Medical Center | Stockbridge | Georgia | 30281 | United States |
| Herman Clinical Research LLC | Suwanee | Georgia | 30024 | United States |
| Laurie Tom, MD | Honolulu | Hawaii | 96813 | United States |
| Pacific Diabetes & Endocrine Center | Honolulu | Hawaii | 96813 | United States |
| Medico | Chicago | Illinois | 60616 | United States |
| Nephrology Associates Northern Illinois and Indiana | Hinsdale | Illinois | 60521 | United States |
| Kidney and Hypertension Center of Wabash Valley LLC | Terre Haute | Indiana | 47804 | United States |
| Ochsner Medical Foundation | Slidell | Louisiana | 70461 | United States |
| University of Maryland Midtown Professionals Group Healthcare | Baltimore | Maryland | 21201 | United States |
| NECCR Primacare Research, LLC | Fall River | Massachusetts | 02721 | United States |
| Healthy Heart Cardiology | Grand Rapids | Michigan | 49546 | United States |
| Care Access Research - Minneapolis | Minneapolis | Minnesota | 55403 | United States |
| Nephrology and Hypertension Associates | Tupelo | Mississippi | 38801 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| The EnLyv Clinics | Edison | New Jersey | 08820 | United States |
| Gaffney Health Services | Charlotte | North Carolina | 28205 | United States |
| Bland Clinic | Greensboro | North Carolina | 27401 | United States |
| Ardmore Medical Research | Winston-Salem | North Carolina | 27103 | United States |
| Panoramic Health | Providence | Rhode Island | 02904 | United States |
| DarSalud Care / LifeDOC Research | Memphis | Tennessee | 38119 | United States |
| Academy of Diabetes Thyroid and Endocrine | El Paso | Texas | 79935 | United States |
| AA Medical Research Center | Flint | Texas | 48504 | United States |
| Clinical Research Stategies Inc | Houston | Texas | 77090 | United States |
| RGV Endocrine Center | McAllen | Texas | 78503 | United States |
| Dallas Renal Group | Plano | Texas | 75093 | United States |
| Tranquil Clinical Research | Webster | Texas | 77598 | United States |
| MultiCare Endocrinology Specialists Tacoma | Tacoma | Washington | 98405 | United States |
| Many Locations | Multiple Locations | Argentina |
| Many Locations | Multiple Locations | Belgium |
| Many Locations | Multiple Locations | Brazil |
| Many Locations | Multiple Locations | Canada |
| Many Locations | Multiple Locations | China |
| Many Locations | Multiple Locations | Denmark |
| Many Locations | Multiple Locations | Germany |
| Many Locations | Multiple Locations | Greece |
| Many Locations | Multiple Locations | Mexico |
| Many Locations | Multiple Locations | Netherlands |
| Many Locations | Multiple Locations | Portugal |
| Many Locations | Multiple Locations | Saudi Arabia |
| Many Locations | Multiple Locations | Singapore |
| Many Locations | Multiple Locations | Slovenia |
| Many Locations | Multiple Locations | South Korea |
| Many Locations | Multiple Locations | Switzerland |
| Many Locations | Multiple Locations | Taiwan |
| Many Locations | Multiple Locations | Thailand |
| Derived |
| Desai NR, Navaneethan SD, Nicholas SB, Pantalone KM, Wanner C, Hamacher S, Gay A, Wheeler DC. Design and rationale of FINE-REAL: A prospective study of finerenone in clinical practice. J Diabetes Complications. 2023 Apr;37(4):108411. doi: 10.1016/j.jdiacomp.2023.108411. Epub 2023 Feb 2. |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C576501 | finerenone |
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