RECRUITING

An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

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 which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems. The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone. The data will come from a network of commercial electronic health records (EHRs) and national claims data in the United States and in Asia. They cover the period from July 1st, 2021 until the latest data cut available for each dataset. Only already available data is collected and studied. There are no required visits or tests in this study.

Official Title

Finerenone Research of Outcomes and Drug Utilization

Quick Facts

Study Start:2024-05-15
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06278207

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. * A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used
  2. * No recorded prescription for finerenone in the 12 months prior to the index date
  3. * Age of 18 years or older as of the index date
  4. * Evidence of T2D at any point before (and including) the index date.
  5. * CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:
  6. * A diagnosis code indicating CKD stage 2, 3, 4 or stage unspecified
  7. * two UACR tests results ≥ 30 mg/g separated by at least 90 days and by not more than 540 days
  8. * two different eGFR test results ≥ 15 mL/min/1.73 m2 AND \< 60 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days
  1. * Two different eGFR test results \< 15 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days;
  2. * Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period);
  3. * A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Many Locations
Multiple Locations, New Jersey, 07981
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 Date2024-05-15
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-05-15
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Kidney Disease
  • Type 2 Diabetes Mellitus