RECRUITING

A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 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 finerenone treatment too early * 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 September 2027.

Official Title

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

Quick Facts

Study Start:2022-06-13
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05348733

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult participants of all genders (≥18 years old)
  2. * Diagnosis of CKD associated with T2D based on assessment by physician.
  3. * Treatment according to local marketing authorization, finerenone 20 or 10 mg.Treatment should have been started up to 8 weeks before or after the ICF is signed.
  4. * Decision to initiate treatment with finerenone must be made before ICF is signed.
  5. * Signed informed consent
  1. * Participation in an investigational trial at any time during the course of this study
  2. * Contra-indications according to the local label.

Contacts and Locations

Study Contact

Bayer Clinical Trials Contact
CONTACT
(+)1-888-84 22937
clinical-trials-contact@bayer.com

Study Locations (Sites)

Nephrology Consultants LLC
Huntsville, Alabama, 35805
United States
AKDHC Medical Research Servies LLC
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
Keck School of Medicine of University of Southern California
Los Angeles, California, 90033
United States
UCSF Nephrology Clinic
San Francisco, California, 94143
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
Ellipsis Group
Alpharetta, Georgia, 30022
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
Cook County Health
Chicago, Illinois, 60612
United States
Jesse Brown VA Medical Center
Chicago, Illinois, 60612
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
University of Iowa Preventive Intervention Clinic
Iowa City, Iowa, 52242
United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101
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
Jackson Medical Mall University Home Dialysis Clinic
Jackson, Mississippi, 39213
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
Prolato Clinical Research
Houston, Texas, 77054
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
University of Utah
Salt Lake City, Utah, 84108
United States
Washington Nephrology Associates
Alexandria, Virginia, 22304
United States
MultiCare Endocrinology Specialists Tacoma
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Bayer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-13
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2022-06-13
Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Kidney Disease
  • Type 2 Diabetes Mellitus