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

NCT06278207 | Recruiting

• 1 other identifier: 22731
• Study Type: observational
• Target: 50,000
• Locations: 4 countries
• Sites: 4

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (3)

• Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.

  Sociodemographic characteristics such as age, sex, race and socio-economic status.

  12 months before first prescription/dispensation of finerenone (index date)

• Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone.

  Including heart diseases, lipid diseases, liver disease, hospitalization for acute kidney injury, dementia, body mass index, smoking status, alcohol abuse, and other comorbidities measured using comorbidities indexes (such as the Charlson comorbidity index)

  12 months before first prescription/dispensation of finerenone (index date)

• Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone.

  In subcohorts of participants in co-medication between finerenone and other hypertensive and diabetic medications (SGLT2i, RAASi, GLP-1 RA, etc.), characterized by CKD stage, including a 15-25 ml/min/1.73 m2 eGFR subgroup.

  12 months before first prescription/dispensation of finerenone (index date)

Secondary Outcomes (15)

• Proportion of finerenone initiators with and without UACR measurements at baseline

  From first prescription/dispensation of finerenone (index date) until 12 months after index date

• Average UACR in the subcohort with UACR measurements

  From first prescription/dispensation of finerenone (index date) until 12 months after index date

• Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone.

  From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months

• Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone.

  From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months

• Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone.

  From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months

Study Arms (1)

Adult patients with CKD and T2D who initiate finerenone

The data sources used include a network of commercial electronic health records (EHRs) and national claims data in Asia and in the United States.

Drug: Finerenone (BAY 94-8862)

Interventions

Finerenone (BAY 94-8862) DRUG

10 mg or 20 mg daily

Also known as: Kerendia, Firialta

Adult patients with CKD and T2D who initiate finerenone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chronic kidney disease and type 2 diabetes who initiate finerenone in secondary data sources (electronic health records (EHR) and claims data) in the United States and in Asia.

You may qualify if:

• 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
• No recorded prescription for finerenone in the 12 months prior to the index date
• Age of 18 years or older as of the index date
• Evidence of T2D at any point before (and including) the index date.
• 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:
• A diagnosis code indicating CKD stage 2, 3, 4 or stage unspecified
• two UACR tests results ≥ 30 mg/g separated by at least 90 days and by not more than 540 days
• 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

You may not qualify if:

• \- Kidney failure defined as follows:
• Two different eGFR test results \< 15 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days;
• Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period);
• A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant

Sponsors & Collaborators

• Bayer: lead

Study Sites (4)

Many Locations

Multiple Locations, New Jersey, 07981, United States

COMPLETED

Bayer

Berlin, 13353, Germany

RECRUITING

Many Locations

Multiple Locations, Japan

COMPLETED

Many Locations

Multiple Locations, Taiwan

COMPLETED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

finerenone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 26, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); US (1); JP (1); TW (1)