Bayer

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A clinical trial for non-diabetic chronic kidney disease patients.

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

Trial ID: NCT05047263

Clinical trials still provide the safest and -- given the important potential for improving health for millions -- the fastest way to keep medicine moving forward. — Glenn D Braunstein, MD

Trial 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.

Estimated Enrollment

1580 Participants

Phase

Eligibility Criteria

Participants must:

Participants must not:

Key Criteria List

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)

Commitments from you

You will need to travel to one of the 58 sites taking part in this clinical trial. Sites are located in:

Actively Recruiting

Kansas City, Kansas, United States
McAllen, Texas, United States
Boston, Massachusetts, United States
Chapel Hill, North Carolina, United States
Orlando, Florida, United States
San Dimas, California, United States
Woodbridge, Virginia, United States
Boca Raton, Florida, United States
Los Angeles, California, United States
Jackson, Mississippi, United States
Norfolk, Virginia, United States
Iowa City, Iowa, United States
Greenville, North Carolina, United States
Cleveland, Ohio, United States
Spokane, Washington, United States
St. Louis, Missouri, United States
New Haven, Connecticut, United States
Shenandoah, Texas, United States
Huntsville, Alabama, United States

Not yet Recruiting

(Awaiting confirmation) Wichita, Kansas, United States
(Awaiting confirmation) Chicago, Illinois, United States
(Awaiting confirmation) Baltimore, Maryland, United States
(Awaiting confirmation) Aurora, Colorado, United States
(Awaiting confirmation) Fairfax, Virginia, United States
(Awaiting confirmation) Knoxville, Tennessee, United States
(Awaiting confirmation) Kansas City, Missouri, United States
(Awaiting confirmation) Salt Lake City, Utah, United States
(Awaiting confirmation) Hinsdale, Illinois, United States
(Awaiting confirmation) Detroit, Michigan, United States
(Awaiting confirmation) Chula Vista, California, United States
(Awaiting confirmation) Middlebury, Connecticut, United States
(Awaiting confirmation) South Gate, California, United States
(Awaiting confirmation) Nashville, Tennessee, United States
(Awaiting confirmation) Witchita, Kansas, United States
(Awaiting confirmation) Bethlehem, Pennsylvania, United States
(Awaiting confirmation) El Paso, Texas, United States
(Awaiting confirmation) Edina, Minnesota, United States
(Awaiting confirmation) Asheville, North Carolina, United States
(Awaiting confirmation) Shreveport, Louisiana, United States
(Awaiting confirmation) Atlanta, Georgia, United States
(Awaiting confirmation) Orangeburg, South Carolina, United States
(Awaiting confirmation) Dallas, Texas, United States
(Awaiting confirmation) Providence, Rhode Island, United States
(Awaiting confirmation) Danville, Pennsylvania, United States
(Awaiting confirmation) San Antonio, Texas, United States
(Awaiting confirmation) Houston, Texas, United States
(Awaiting confirmation) Waterbury, Connecticut, United States
(Awaiting confirmation) Springfield, Massachusetts, United States
(Awaiting confirmation) Philadelphia, Pennsylvania, United States
(Awaiting confirmation) Cleveland, Ohio, United States
(Awaiting confirmation) Macon, Georgia, United States
(Awaiting confirmation) Augusta, Georgia, United States
(Awaiting confirmation) Wilmington, North Carolina, United States
(Awaiting confirmation) Albuquerque, New Mexico, United States

Potential Benefits

Treatment in trials is investigational as effectiveness and safety have not been established. There is no guarantee that they will become commercially available.

Potential alleviation of symptoms
Regular health check ups
Help others by contributing to medical knowledge

Frequently Asked Questions (FAQs)

How can I check to see if I am eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by finding the ‘Get Started’ button.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of new treatments. A research plan or protocol is created that outlines how trial participants may receive interventions which can include investigational medications, devices, or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo with no active investigational medication, or to no intervention at all. The trial team will share more details before you participate.

Can I stop the trial at anytime?

You can leave the study at any time by telling your study doctor that you no longer want to take part. Your choice will not change the quality of care you receive outside of this study.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include:

Your name, address, telephone number, health insurance number where applicable.
Your age, gender, ethnic and racial background.
Lifestyle information; health and medical history.
Your study treatments and response to study treatments.
Data resulting from testing your biological samples and any images taken.

Who has access to your personal information?

All your personal information collected for this study will be stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by Informa to contact you about clinical trials and related information.