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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 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 2,712-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (66% higher). The trial reports 20 study locations across 11 states.

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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

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

FieldValue
Enrollment Target 4,500 participants
Start Date 2022-06-13
Est. Completion 2026-12-15

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT05348733

The ClinicalTrials.gov registry entry for NCT05348733 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 4,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,712-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (66% higher). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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