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Completed

NCT Number: NCT05047263

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

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.

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Key information

Conditions

Non-diabetic Chronic Kidney Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asociacion de Fomento y Sala de Primeros Auxilios Alberto Mignaburu | Berazategui, Argentina, Berazategui, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

finerenone (BAY94-8862)

Drug

Tablet, 10 mg or 20 mg, once daily (OD), oral

Placebo

Drug

Tablet, once daily, oral

Primary outcomes

  1. Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.

    Time frame: From baseline to month 32

    eGFR: Estimated glomerular filtration rate

Secondary outcomes

  1. Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death

    Time frame: Up to end of study visit (up to approximately 49 months)

  2. Time to the composite of kidney failure or sustained eGFR decline of >= 57%

    Time frame: Up to end of study visit (up to approximately 49 months)

  3. Time to the composite to heart failure hospitalization or CV death

    Time frame: Up to end of study visit (up to approximately 49 months)

  4. Number of participants with Treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESI)

    Time frame: Up to approximately 50 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of FInerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Patients With Non-Diabetic Chronic Kidney Disease

Acronym: FIND-CKD

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Sep 17, 2021
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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