Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Anjay Rastogi (ucla)

Description

Summary

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.

Official 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

Keywords

Non-diabetic Chronic Kidney Disease, Kidney Diseases, Chronic Renal Insufficiency, Finerenone (BAY94-8862)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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/1.73m2 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 CAN'T join 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)

Locations

  • University of California, Los Angeles | UCLA Health Division of Nephrology
    Los Angeles California 90095 United States
  • Balboa Nephrology Medical Group - Poway
    Poway California 92064 United States
  • United Clinical Research & Innovations
    S. Gate California 90280 United States
  • California Institute of Renal Research - Chula Vista
    Chula Vista California 91910 United States

Lead Scientist at University of California Health

  • Anjay Rastogi (ucla)
    Professor of Clinical, Medicine. Authored (or co-authored) 90 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bayer
Links
Click here to find further information and, after study completion, the study results according to Bayer's transparency standards
ID
NCT05047263
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 1584 people participating
Last Updated