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A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting
NCT05348733 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- DRUG Kerendia (Finerenone, BAY94-8862)
Study Locations (20)
Florida
- University of Central Florida College of Medicine — Orlando
- Gulf View Medical — Port Charlotte
- Hanson Clinical Research Center — Port Charlotte
- Metabolic Research Institute — West Palm Beach
Georgia
- Augusta University — Augusta
- Coastal Medical Research — Brunswick
- Caritas Medical Center — Stockbridge
- Herman Clinical Research LLC — Suwanee
California
- Kidney Disease Medical Group — Glendale
- Renal Consultants Medical Group — Granada Hills
Hawaii
- Laurie Tom, MD — Honolulu
- Pacific Diabetes & Endocrine Center — Honolulu
Illinois
- Medico — Chicago
- Nephrology Associates Northern Illinois and Indiana — Hinsdale
Alabama
- Nephrology Consultants LLC — Huntsville
Arizona
- AKDHC Medical Research Servies LLC — Phoenix
Arkansas
- Harrisburg Family Medical Center — Harrisburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,500 participants |
| Start Date | 2022-06-13 |
| Est. Completion | 2026-12-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05348733
The ClinicalTrials.gov registry entry for NCT05348733 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention — of which Kerendia (Finerenone, BAY94-8862) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05348733 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Georgia, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05348733 about?
NCT05348733 is a clinical study titled "A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting". 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...
What is the current status of trial NCT05348733?
This trial is currently active not recruiting. The enrollment target is 4,500 participants. The study started on 2022-06-13. Estimated completion is 2026-12-15.
What conditions does trial NCT05348733 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Chronic Kidney Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05348733?
The interventions under investigation include: Kerendia (Finerenone, BAY94-8862) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05348733?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05348733 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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