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NCT05348733 · ClinicalTrials.gov registry record
A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting
A clinical trial of Type 2 Diabetes Mellitus and Chronic Kidney Disease, sponsored by Bayer.
- Active
- Registry status
- 4,500
- Enrollment target
- 20
- Study locations
NCT05348733: Active study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, sponsored by Bayer.
NCT05348733 is a study of Type 2 Diabetes Mellitus and Chronic Kidney Disease that is active but no longer recruiting, run by Bayer. The registered enrollment target is 4,500 participants, above the 2,925-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (54% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05348733, a study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, is active but no longer recruiting, sponsored by Bayer.
- ACTIVE NOT RECRUITING
- Registry status
- 4,500 participants
- Enrollment target
- 20
- Study locations
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 |
What the registry record for NCT05348733 still lists
NCT05348733 is an observational study that tracks outcomes without assigning an intervention. Its 4,500 participants enrollment target places it among the larger protocols in the corpus, above the 2,925-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (54% higher).
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.
NCT05348733 names 20 study sites across 11 states, led by Florida, Georgia, California.
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.
What interventions are being tested in trial NCT05348733?
The interventions under investigation include: Kerendia (Finerenone, BAY94-8862) (DRUG).
Who is sponsoring clinical trial NCT05348733?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05348733's enrollment target sits among peer trials
4,500 6th of 130 higher than 125 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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