Finerenone Research of Outcomes and Drug Utilization

Plain English Summary

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 is a Not Applicable clinical trial sponsored by Bayer studying Chronic Kidney Disease, Type 2 Diabetes Mellitus. This study observes how the drug finerenone is used in real-world settings for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). It is for adults diagnosed with both CKD and type 2 diabetes who are already prescribed finerenone by their doctor. Participation involves researchers collecting existing health data from electronic health records and insurance claims; no new visits or tests are required. There are no direct alternatives offered within this study, as it observes current treatment practices. The trial aims to enroll 50000 participants.

Official 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

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a diagnosis of type 2 diabetes and CKD stages 2-4. Patients must have been enrolled in a healthcare database for at least 12 months and not have had a finerenone prescription in the year prior to the study's start date. Individuals with kidney failure, those on dialysis, or who have had a kidney transplant cannot participate. This trial is studying Chronic Kidney Disease, Type 2 Diabetes Mellitus, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes will describe the typical characteristics, other health issues, and other medications used by patients starting finerenone, helping doctors understand who is receiving this treatm The specific primary outcome measures are: Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone. (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. (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. (12 months before first prescription/dispensation of finerenone (index date)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it will provide crucial real-world data on the safety and effectiveness of finerenone, filling a gap in understanding how this newly approved medication performs outside of This research targets Chronic Kidney Disease, Type 2 Diabetes Mellitus, where improved treatment options are needed.

Investor Insight

This observational study by Bayer, a major pharmaceutical company, signals a focus on understanding the market adoption and real-world performance of finerenone, a drug for a large patient population, The large enrollment target of 50000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if finerenone is appropriate for your specific condition and if this observational study is a good fit for you. Understand that your existing medical information will be reviewed, but you will not receive any new treatments or interventions as part of this study. Your participation is based on your doctor's prescription of finerenone as part of your standard care. This trial is currently recruiting participants. The trial is being conducted at 4 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 50,000 participants

Interventions

• DRUG: Finerenone (BAY 94-8862) — 10 mg or 20 mg daily

Primary Outcomes

• Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone. (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. (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. (12 months before first prescription/dispensation of finerenone (index date))

Secondary Outcomes

• 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)

Full Eligibility Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

\- 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

Trial Locations

• Many Locations, Multiple Locations, New Jersey, United States
• Bayer, Berlin, Germany
• Many Locations, Multiple Locations, Japan
• Many Locations, Multiple Locations, Taiwan

Frequently Asked Questions

Related Conditions

• Chronic Kidney Disease
• Type 2 Diabetes Mellitus
• Diabetic Nephropathy
• Cardiovascular Disease
• Heart Failure
• Hypertension
• Mineralocorticoid Receptor Antagonism
• Renal Impairment
• Metabolic Syndrome
• End-Stage Renal Disease

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