Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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 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 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 of finerenone treatment - 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 November 2025.

Official Title

FINE-REAL: A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting

Keywords

Chronic Kidney Disease Type 2 Diabetes Mellitus Kidney Diseases Renal Insufficiency, Chronic Diabetes Mellitus, Type 2 Kerendia (Finerenone, BAY94-8862)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adult female or male patient (≥18 years old)
  • Diagnosis of CKD associated with T2D based on assessment by physician.
  • Treatment initiation with finerenone was made as per local label.
  • Decision to initiate treatment with finerenone must be made before ICF is signed
  • Signed informed consent

You CAN'T join if...

  • Participation in an investigational trial at any time during the course of this study
  • Contra-indications according to the local label.

Locations

  • UCSF Nephrology Clinic not yet accepting patients
    San Francisco California 94143 United States
  • Renal Consultants Medical Group accepting new patients
    Granada Hills California 91344 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Bayer
Links
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
ID
NCT05348733
Study Type
Observational
Participants
Expecting 4000 study participants
Last Updated