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

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-diabetic Chronic Kidney Disease

In brief

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 facts

Study ID

NCT05047263

Run by

Bayer

People needed

1584

Starts

2021-09-21

Expected to finish

2026-02-02

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical diagnosis of chronic kidney disease and:
• Urine albumin/creatinine ratio (UACR) of ≥ 200 but ≤ 3500 mg/g and estimated glomerular filtration rate (eGFR) ≥ 25 but < 90 mL/min/1.73m\^2 at screening, and
• Documentation of albuminuria/proteinuria in the participant's medical records at least 3 months prior to screening.
• Stable and maximum tolerated labeled dose of an Angiotensin-converting enzyme inhibitor (ACEI) or Angiotensin receptor blocker (ARB) for at least 4 weeks prior to screening
• K+ ≤ 4.8 mmol/L at screening

You may not qualify if…

• Established diagnosis of Type 1 or 2 Diabetes mellitus, or HbA1c ≥ 6.5% (48 mmol/mol)
• Autosomal dominant or autosomal recessive polycystic kidney disease
• Lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (ANCA) -associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
• Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs)

Where it is running

• Nephrology Consultants, LLC — Huntsville, Alabama, United States
• Balboa Research SMO+ - Chula Vista - West — Chula Vista, California, United States
• Balboa Research SMO+ - El Centro — El Centro, California, United States
• UCLA Clinical and Translational Research Center - Nephrology — Los Angeles, California, United States
• Balboa Nephrology Medical Group - Poway — Poway, California, United States
• North America Research Institute - San Dimas — San Dimas, California, United States
• United Clinical Research & Innovations — South Gate, California, United States
• University of Colorado | Renal Research Office — Aurora, Colorado, United States
• DaVita Clinical Research | Middlebury, CT — Middlebury, Connecticut, United States
• Yale University | Nephrology Clinical Research — New Haven, Connecticut, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Research Physicians Network Alliance — Boca Raton, Florida, United States
• Florida Kidney Physicians - Boca Raton — Boca Raton, Florida, United States
• AdventHealth Translational Research Institute — Orlando, Florida, United States
• Grady Memorial Hospital - Endocrinology — Atlanta, Georgia, United States
• Southeastern Clinical Research Institute, LLC — Augusta, Georgia, United States
• Central Georgia Kidney Specialists - Macon — Macon, Georgia, United States
• Frenova Renal Research | Boise Kidney and Hypertension — Meridian, Idaho, United States
• Northwestern Medicine - Feinberg School of Medicine - Nephrology and Hypertension — Chicago, Illinois, United States
• Research by Design, LLC | Chicago, IL — Chicago, Illinois, United States
• Nephrology Associates of Northern Illinois and Indiana - Hinsdale — Hinsdale, Illinois, United States
• University of Iowa Health Care Medical Center - Cardiology — Iowa City, Iowa, United States
• KUMC Clinical and Translational Science Unit - Nephrology — Kansas City, Kansas, United States
• Kansas Nephrology Research Institute — Wichita, Kansas, United States
• Nefromed s.r.o. — Prague, Czechia

Full record on ClinicalTrials.gov

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