Observational Study on Finerenone for Chronic Kidney Disease and Type 2 Diabetes

This is an observational study called FINEROD that looks at how the treatment finerenone (BAY 94-8862) is used in real-world settings for people with chronic kidney disease (CKD) and type 2 diabetes (T2D). Researchers want to learn more about how safe and effective finerenone is. You could join if you are 18 or older, have CKD and T2D, and are already taking finerenone as part of your regular medical care. The study will look at your health information, including your characteristics, other health conditions, and other medications, from 12 months before you started finerenone. This study is currently unclear about its recruitment status and plans to include 50,000 participants.

Study design
This is an observational study, meaning researchers will only collect information from existing medical records without giving specific advice or treatments. It aims to include 50,000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study looks at your characteristics, comorbidities, and comedications at 12 months before you started finerenone.

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NCT06278207

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

Recruiting
Not specifiedAges 18+Observational
Bayer
~50,000 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Finerenone (BAY 94-8862)

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
Measured over 12 months before first prescription/dispensation of finerenone (index date)
+2 more outcomes measured
Chronic Kidney Disease
Type 2 Diabetes Mellitus
4 sites across 4 states
New Jersey1
Germany1
Japan1
Taiwan1

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Eligibility criteria

Inclusion

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

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
  • 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)

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

  • 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)

    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)

  • 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)

    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.