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

Type 2 Diabetes Mellitus Clinical Trial

— FIRST-2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05703880
• Other study ID #: 22381
• Status: Active, not recruiting
• Start date: June 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Finerenone (Kerendia, BAY948862)
Retrospective cohort analysis using United States Optum EHR data and OM1 RWDC databases.

Locations

Country	Name	City	State
United States	OM1 Real-World Data Cloud (RWDC)	Boston	Massachusetts
United States	Optum electronic health records (EHR) database	Eden Prairie	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in the US.		Up to 365 days
Primary	Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in the US.		Up to 365 days
Primary	Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in the US.		Up to 180 days
Secondary	Incidence rate of composite renal outcomes		Up to 18 months
Secondary	Incidence rate of composite cardiovascular outcomes		Up to 18 months
Secondary	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
Secondary	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
Secondary	Incidence rate of hyperkalemia		Up to 18 months
Secondary	Incidence of hospitalization associated with a hyperkalemia event		Up to 18 months
Secondary	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
Secondary	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
Secondary	Change in level of serum potassium between baseline and end of follow up visit after initiating finerenone		Up to 18 months
Secondary	Incidence rates of the respective component outcomes of the CV and renal composite outcomes		Up to 18 months
Secondary	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

External Links

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