50,000 patients to reveal how new kidney drug works in real life

NCT ID NCT06278207

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study will follow 50,000 people in Asia and the United States who have chronic kidney disease and type 2 diabetes and are already taking finerenone as part of their regular care. Researchers will collect data from electronic health records and insurance claims to understand patient characteristics, how the drug is used, and its safety and effectiveness in real-world conditions. No additional visits or tests are required.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Finerenone (Kerendia, Firialta)
What this could lead to: If successful, this study could provide a clearer picture of how finerenone works in everyday medical practice, helping doctors better understand its benefits and risks for people with kidney disease and diabetes.
What could go wrong: This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by differences in patient care or data quality, and no new treatment is being tested.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients with chronic kidney disease and type 2 diabetes who initiate finerenone in secondary data sources (electronic health records (EHR) and claims data) in the United States and in Asia.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease Type 2 diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

50,000 patients to reveal how new kidney drug works in real life

What the study statuses mean