An Observational Study Called FIRST-2.0 to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

NCT ID: NCT05703880

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15948 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-10-01

Brief Summary

This is an observational study, in which data from people in the United States (US) 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 finerenone treatment as prescribed by their doctors. To do this, the researchers will collect data on:

• general information of the participants such as age or gender
• any other disease or medical condition in the participants
• other medications used while taking finerenone.

The researchers will also collect data on kidney function and possible heart problems to find out how well finerenone works. Additionally, medical problems possibly related to finerenone treatment will be collected to learn more about how safe finerenone is in real-world use.

The data will come from US databases Optum Electronic Health Records (EHR) and OM1 Real-World Data Cloud (RWDC). They will cover the period from July 2021 to May 2023.

Only already available data is collected and studied. There are no required visits or tests in this study.

Conditions

Chronic Kidney Disease; Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Finerenone (Kerendia, BAY948862)

Adults with CKD and T2D from the USA who initiate finerenone.

Finerenone (Kerendia, BAY948862)

Intervention Type: DRUG

Retrospective cohort analysis using United States Optum EHR data and OM1 RWDC databases.

Interventions

Finerenone (Kerendia, BAY948862)

Retrospective cohort analysis using United States Optum EHR data and OM1 RWDC databases.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Minimum of 12 months continuous enrolment in the EHR databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR system.
• No recorded prescription of finerenone prior to the index date.
• Age 18 years or older as of the index date.
• T2D diagnosis at any point before (and including) the index date using the same algorithms applicable to the specific data source as in previous studies of the FIRST program.
• 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 OR
• Two Urinary Albumin-to-Creatinine Ratio (ACR) test results ≥ 30 mg/g separated by at least 90 days and no more than 540 days OR
• Two different eGFR test results ≥ 15 mL/min/1.73 m*2 AND < 60 mL/min/1.73 m*2 separated by at least 90 days and no more than 540 days.

Exclusion Criteria

• Type 1 diabetes identified by appropriate algorithms in the data source
• Kidney cancer on or before the index date
• Kidney failure defined as:

• Two different eGFR test results < 15 mL/min/1.73 m*2 separated by at least 90 days and no 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 (International Classification of Diseases, 10th Revision)
• Kidney transplant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OM1 Real-World Data Cloud (RWDC)

Boston, Massachusetts, United States

Optum electronic health records (EHR) database

Eden Prairie, Minnesota, United States

Countries

United States

References

Vizcaya D, Kovesdy CP, Reyes A, Pessina E, Pujol P, James G, Oberprieler NG. Characteristics of patients with chronic kidney disease and Type 2 diabetes initiating finerenone in the USA: a multi-database, cross-sectional study. J Comp Eff Res. 2023 Aug;12(8):e230076. doi: 10.57264/cer-2023-0076. Epub 2023 Jun 30.

Reference Type: DERIVED

PMID: 37387399 (View on PubMed)

Related Links

https://clinicaltrials.bayer.com/

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.

Other Identifiers

22381

Identifier Type: -

Identifier Source: org_study_id