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150,000 patients tracked: does finerenone protect hearts in kidney disease and diabetes?

NCT ID NCT06608212

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This observational study follows 150,000 people with chronic kidney disease and type 2 diabetes to see how finerenone (Kerendia) works in everyday medical care. Researchers will compare those taking finerenone to those not taking it, looking at rates of heart attacks and heart failure hospitalizations. No extra visits or tests are required—only existing health records are used.

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)
What this could lead to
If successful, this study could confirm that finerenone is safe and effective for preventing heart attacks and heart failure hospitalizations in real-world patients with CKD and T2D.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It only looks at existing data, so it cannot prove cause and effect.

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 150,000 people

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

Started

Oct 2024

Expected to finish

Jun 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

Adults with CKD and T2D who are eligible for finerenone prescription after the approval of finerenone in the US. The study cohort will identify patients who initiate finerenone and a comparator group of individuals with CKD and T2D not using finerenone. All eligible adult individuals (aged ≥ 18 years) in the data source will be selected for the study cohort without sampling from the source population. There will be no restrictions of the study population based on sex, race, or ethnicity.

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 on or before Time 0 (Time 0 = finerenone initiation date) : * Active registration or continuous enrolment for at least 365 days in the data source before Time 0 (days \[-365, 0\]) * No recorded use of finerenone before Time 0 (days \[-all available, 0\]) * Aged 18 years or older on Time 0 * Diagnosis of T2D at any time on or before Time 0 (days \[-all available, 0\]) * Having a diagnosis code indicating CKD stage 1, 2, 3, 4, or stage unspecified on or before Time 0 (days \[-all available, 0\]) Exclusion criteria on or before Time 0: * Finerenone users who are hospitalized or admitted for an emergency department visit on Time 0 * Type 1 diabetes (T1D) at any time on or before Time * Evidence of end-stage kidney disease (ESKD) at any time on or before Time 0 * A diagnosis of kidney cancer at any time on or before Time 0 * A diagnosis of adrenal insufficiency at any time on or before Time 0 * Evidence of hepatic impairment at any time on or before Time 0 * An eGFR measurement \< 25 mL/min/1.73 m2 on or in the 90 days before Time 0 * Evidence of recent increased serum potassium or hyperkalaemia * Use of a strong CYP3A4 inhibitor on or in the 183 days before Time 0 * Evidence of pregnancy measured on or in the 40 weeks before Time 0

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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

Contacts and locations

Locations

  • Bayer

    Whippany, New Jersey, 07981, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.