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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT06522997

Public ClinicalTrials.gov record NCT06522997. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 3:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2b Dose-finding, Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of BAY 3283142 on Top of Standard of Care in Reducing Albuminuria in Patients With Chronic Kidney Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06522997
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Bayer
Industry
Enrollment
1,222 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 7, 2024
Primary completion
Oct 23, 2025
Completion
Nov 19, 2025
Last update posted
Apr 12, 2026

2024 – 2025

United States locations

U.S. sites
24
U.S. states
11
U.S. cities
23
Facility City State ZIP Site status
Nephrology Consultants, LLC Huntsville Alabama 35805
Balboa Research SMO+ - Chula Vista Chula Vista California 91910
California Kidney Specialists - San Dimas San Dimas California 91773
Yale Nephrology Clinical Research Clinic New Haven Connecticut 06510
Nova Clinical Research - Blake Medical Center Bradenton Florida 34209
Renstar Medical Research - Deerwood Clinic Ocala Florida 34471
Elixia Central Florida Orlando Florida 32608
Florida Institue for Clinical Research Orlando Florida 32825
Southeastern Clinical Research Institute, LLC Augusta Georgia 30904
Research by Design, LLC | Chicago, IL Chicago Illinois 60643
Nephrology Associates of Northern Illinois and Indiana - Hinsdale Hinsdale Illinois 60521
Triad Internal Medicine - Asheboro Asheboro North Carolina 27203
Eastern Nephrology Associates - New Bern New Bern North Carolina 28562
Brookview Hills Research Associates, LLC Winston-Salem North Carolina 27103
Knoxville Kidney Center, PLLC Knoxville Tennessee 37923
Vanderbilt University Medical Center - Nephrology Clinical Trials Center Nashville Tennessee 37232
Renal Disease Research Institute | Landry Dallas Texas 75246
Southwest Houston Research, Ltd. Houston Texas 77099
Clinical Advancement Center, PLLC San Antonio Texas 78212
Utah Kidney Research Institute | Salt Lake City, UT South Salt Lake Utah 84115
Peninsula Kidney Associates - Hampton Hampton Virginia 23666
Manassas Clinical Research Center Manassas Virginia 20110
Salem VA Medical Center - Nephrology Salem Virginia 24153
Mendez Center For Clinical Research | Woodbridge, VA Woodbridge Virginia 22192

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 129 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06522997, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 12, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06522997 live on ClinicalTrials.gov.

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