A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease

Conditions

• Non-diabetic Chronic Kidney Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Finerenone (BAY94-8862) — DRUG
  Tablet, 10 mg or 20 mg, once daily (OD), oral
• Placebo — DRUG
  Tablet, once daily, oral

Study Details

Researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It works by blocking a certain hormone called aldosterone that causes injury and inflammation in the heart and kidney which is known to play a role in CKD. In this trial, the researchers want to learn if finerenone helps to slow down the worsening of the participants' non-diabetic CKD compared to a placebo. A placebo looks like a trial treatment but does not have any medicine in it. The trial will include about 1,580 men and women who are at least 18 years old. The participants will take finerenone or a placebo once a day as tablets by mouth. All of the participants will also continue to take their current medicine for their CKD. The participants will be in the trial for up to about 50 months. During the trial, the doctors will collect blood and urine samples and check the participants' health. The participants will also answer questions about how they are feeling and what adverse events they are having. An adverse event is a medical problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the trial treatments.

Key Dates

Start date

Sep 21, 2021

Status verified

Feb 2026

Primary completion

Dec 31, 2025

Completion

Feb 2, 2026

Study Design

Enrollment

1,584 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Finerenone (BAY94-8862)
  Participants will receive finerenone.
• Placebo Comparator: Placebo
  Participants will receive placebo.

Primary Outcome Measure

Mean rate of change as measured by the total slope of eGFR from baseline to Month-32. [ Time Frame: From baseline to month 32 ]

Locations (57)

Related coverage on Hipa.ai

• Finerenone Completes Phase 3 Trial for Non-diabetic Chronic Kidney Disease
  Finerenone · Dec 31, 2025 · ClinicalTrials.gov

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