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 (FIRST-2)

Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 2.0

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease
• Intervention / Treatment: Drug: Finerenone (Kerendia, BAY948862)

• Study Type: Observational
• Enrollment (Actual): 15948

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • OM1 Real-World Data Cloud (RWDC)
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • Optum electronic health records (EHR) database

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Persons initiating finerenone who have CKD and T2D will be included based on combinations of diagnosis codes of CKD and T2D, respectively, prescriptions and laboratory values (e.g., eGFR values or UACR measurements) indicating CKD and T2D.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Finerenone (Kerendia, BAY948862); Adults with CKD and T2D from the USA who initiate finerenone.	Drug: Finerenone (Kerendia, BAY948862); Retrospective cohort analysis using United States Optum EHR data and OM1 RWDC databases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in the US.	Up to 365 days
Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in the US.	Up to 365 days
Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in the US.	Up to 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of composite renal outcomes		Up to 18 months
Incidence rate of composite cardiovascular outcomes		Up to 18 months
Number of patients who initiate finerenone using a 10 mg dose and number of patients who have up-titrated to a 20 mg dose by 1, 3, 6, and 12 months, respectively.		Up to 18 months
Number of patients who initiate finerenone using a 20 mg dose and number of patients who have down-titrated to a 10 mg dose by 1, 3, 6, and 12 months, respectively		Up to 18 months
Incidence rate of hyperkalemia		Up to 18 months
Incidence of hospitalization associated with a hyperkalemia event		Up to 18 months
Change in eGFR between baseline, at 4 months and end of follow up visit after initiating finerenone	eGFR: Estimated Glomerular Filtration Rate	Up to 18 months
Change in level of serum potassium between baseline and end of follow up visit after initiating finerenone		Up to 18 months
Change in UACR between baseline, at 4 months and end of follow up visit after initiating finerenone	UACR: Urine Albumin to Creatinine Ratio	Up to 18 months
Incidence rates of the respective component outcomes of the CV and renal composite outcomes		Up to 18 months
Incidence rate of proliferative diabetic retinopathy in patients who initiate finerenone with prior non-proliferative diabetic retinopathy	Proliferative diabetic retinopathy is identified by the occurrence of an inpatient or outpatient diagnosis code for proliferative diabetic retinopathy.	Up to 18 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Mellitus, Type 2; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 22381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No