A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease

Last updated: March 11, 2025
Sponsor: Bayer
Overall Status: Active - Recruiting

Phase

2

Condition

Focal Segmental Glomerulosclerosis

Nephropathy

Renal Failure

Treatment

BAY3283142

Placebo

Clinical Study ID

NCT06522997
22040
2023-505755-40-00
  • Ages > 18
  • All Genders

Study Summary

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. A common sign of decreasing kidney function is the body losing too much of a protein called albumin in the urine. This condition is known as albuminuria. This can lead to a faster decline in kidney function. People who have high blood pressure and diabetes are more likely to have CKD and are at a higher risk of complications related to it.

BAY3283142 is a new drug that is being developed to treat people with CKD. It works by activating a protein that helps relax blood vessels and is thought to have beneficial effects in CKD.

In this study, researchers want to learn about how well different doses of BAY3283142 work when taken with standard treatment for CKD in reducing albumin in the urine of participants with CKD. They will compare the results of the change in the urine albumin-creatinine ratio (UACR) after 16 weeks for BAY3283142 with a placebo. A placebo looks like the study drug but does not have any medicine in it.

During the study, participants will take either of the following drugs:

  • BAY3283142: Participants will take BAY3283142 as tablets by mouth.

  • Placebo: Participants will take it in the same way as BAY3283142. Participants will continue taking the available standard treatment for CKD and other conditions they may have (for example, heart conditions and diabetes).

At the start of this study, the researchers will check the medical history and current medications of the participants. They will also perform a complete health check-up of all the participants. Researchers will take urine and blood samples from the participants at different time points to measure UACR and eGFR.

Participants will be divided equally into different groups. Only 1 group will receive placebo and the other groups will receive BAY3283142. Participants will take their assigned treatment for 16 weeks.

No one will know who receives which drug or dose of BAY3283142 during the study.

Participants will be in this study for around 23 weeks. This includes the time for screening before the start of treatment and follow-up with participants after treatment.

People can join this study if they:

  • are 18 years of age or older and have been diagnosed with CKD

  • have poor kidney function according to the eGFR test

  • have abnormally high levels of albumin in the urine according to the UACR test

  • have been taking certain drugs at a stable dose for management of high blood pressure, diabetes, kidney disease, etc. for at least 4 weeks before the start of the study

People cannot join this study if they:

  • have low blood pressure

  • have had a stroke or a heart attack, or were hospitalized because of heart failure in the 3 months before the start of the study

  • have a serious liver disease

  • have a kidney disease for which they need to take drugs that control the immune system The detailed requirements will be discussed between the study doctors and people considering joining this study.

Participants may or may not get the expected benefits of treatment with BAY3283142, but they will receive thorough medical check-ups during this study. These can help to improve individual treatment in the future and to identify unknown medical risks.

Some participants may experience medical problems during this study including pain and discomfort when blood samples are taken. Researchers will closely monitor and manage any medical problems the participants may have. They will not include people who should not take BAY3283142 due to known safety concerns.

The findings from this study may contribute to developing a new treatment option for people with CKD who have excess albumin in the urine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be ≥18 years of age

  • eGFR (Chronic Kidney Disease Epidemiology Collaboration formula) ≥20 and ≤75 mL/min /1.73 m^2 at Screening Note: One re-assessment of eGFR based on central laboratoryvalues is allowed during the Screening period"

  • UACR ≥200 mg/g and <3500 mg/g as determined by the geometric mean (as calculated bythe central laboratory) of 3 morning void urine specimens obtained at Screening

  • Treatment with the highest tolerated labeled dose of either angiotensin-convertingenzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB), unless suchtreatment is either not tolerated or contraindicated. Treatment dose must be stabledose for at least 4 weeks before Screening with no planned change of the therapyduring the study

  • If the participant receives any of the following treatments it should be stable for 4 weeks prior to Screening: sodium-glucose co-transporter-2 (SGLT2) inhibitor,finerenone, diuretics, endothelin-receptor antagonists, or glucagon-like peptide (GLP) receptor agonist

Exclusion

Exclusion Criteria:

  • Systolic blood pressure (SBP) <100 mmHg at Visit 2 (baseline)

  • Patients with a tendency for clinically relevant orthostatic hypotension atScreening and Visit 2 (baseline) as judged by the investigator

  • SBP ≥160 mmHg, unless treated with ≥3 blood pressure lowering medications, atScreening or at Visit 2 (baseline)

  • History of secondary hypertension other than CKD

  • Hepatic impairment corresponding to Child-Pugh B or C or other significant liverdisease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated bye.g. AST or ALT >3x ULN or total bilirubin >2x ULN) at Screening

  • Polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis and anyother kidney disease requiring immunosuppressive therapy within 6 months prior toScreening

Study Design

Total Participants: 700
Treatment Group(s): 2
Primary Treatment: BAY3283142
Phase: 2
Study Start date:
August 08, 2024
Estimated Completion Date:
March 17, 2026

Connect with a study center

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    Site Not Available

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    San Luis, D5702AAX
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  • Saiseikai Yokohamashi Nanbu Hospital

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  • Rinku General Medical Center

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  • Japanese Red Cross Fukuoka Hospital

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  • Ehime Prefectural Central Hospital

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  • Nara Prefecture General Medical Center

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    Japan

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  • Osaka General Medical Center

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    Japan

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  • Japanese Red Cross Saitama Hospital

    Saitama, 330-8553
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  • Yonsei University Wonju Christian Hospital

    Wonju, Gang''weondo 26426
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  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggido 14068
    Korea, Republic of

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  • Korea University Anam Hospital

    Seoungbuk-gu, Seoul 02841
    Korea, Republic of

    Site Not Available

  • Korea University Ansan Hospital

    Gyeonggi-do, 425-707
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 5505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722
    Korea, Republic of

    Site Not Available

  • Hospital Garcia de Orta | Research Department

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    Torres Novas, Santarém 2350-754
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  • Centro Clinico Academico Braga | Braga, Portugal

    Braga, 4710-243
    Portugal

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    Coimbra, 3000-075
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  • CHUC- Hospitais da Universidade de Coimbra - Nephrology Department

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    Slovakia

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    Slovakia

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    Taiwan

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    Taiwan

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    United Kingdom

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    United Kingdom

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    London, SE5 9RJ
    United Kingdom

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    London, SE5 9RJ
    United Kingdom

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    London, NW3 2QG
    United Kingdom

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    London, E1 1FR
    United Kingdom

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    Manchester, M13 9WL
    United Kingdom

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    Northamptonshire, NN17 2UR
    United Kingdom

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  • Nephrology Consultants, LLC

    Huntsville, Alabama 35805-4104
    United States

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    Chula Vista, California 91911
    United States

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    Chula Vista, California 91911
    United States

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    La Mesa, California 91942-3059
    United States

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    San Dimas, California 91773-3538
    United States

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    San Dimas, California 91773
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    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Nova Clinical Research | Brandenton, FL

    Bradenton, Florida 34209
    United States

    Active - Recruiting

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • Elixia Central Florida

    Orlando, Florida 32608
    United States

    Site Not Available

  • Florida Institue for Clinical Research

    Orlando, Florida 32825
    United States

    Active - Recruiting

  • Southeastern Clinical Research Institute, LLC

    Augusta, Georgia 30904
    United States

    Active - Recruiting

  • Research by Design, LLC | Chicago, IL

    Chicago, Illinois 60643
    United States

    Active - Recruiting

  • Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Triad Internal Medicine

    Asheboro, North Carolina 27203-5573
    United States

    Active - Recruiting

  • Eastern Nephrology Associates - New Bern

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Knoxville Kidney Center (KKC), PLLC

    Knoxville, Tennessee 37923-3624
    United States

    Active - Recruiting

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee 37923-3624
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Renal Disease Research Institute | Landry

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Southwest Houston Research, Ltd.

    Houston, Texas 77099
    United States

    Site Not Available

  • Clinical Advancement Center, PLLC

    San Antonio, Texas 78212
    United States

    Active - Recruiting

  • DaVita Clinical Research | Westover Hills, San Antonio, TX

    San Antonio, Texas 78251
    United States

    Site Not Available

  • DaVita Clinical Research | North Houston, TX

    Shenandoah, Texas 77384
    United States

    Site Not Available

  • DaVita Clinical Research | North Houston, TX

    Woodland Hills, Texas 77384
    United States

    Site Not Available

  • Utah Kidney Research Institute | Salt Lake City, UT

    S. Salt Lake, Utah 84115
    United States

    Site Not Available

  • Peninsula Kidney Associates

    Hampton, Virginia 23666
    United States

    Active - Recruiting

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • Salem VA Medical Center - Cardiology

    Salem, Virginia 24153
    United States

    Active - Recruiting

  • Salem Veterans Affairs Healthcare System

    Salem, Virginia 24153-6404
    United States

    Site Not Available

  • Mendez Center For Clinical Research | Woodbridge, VA

    Woodbridge, Virginia 22192
    United States

    Active - Recruiting

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