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

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.

Conditions

• Chronic Kidney Disease

Interventions

DRUG

BAY3283142

Tablet, intake orally once daily

DRUG

Placebo

Matching with BAY3283142

Sponsors & Collaborators

• Bayer

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-08

Primary Completion

2025-10-24

Completion

2025-11-20

FDA Drug

Yes

Countries

• United States
• Argentina
• Belgium
• China
• Greece
• India
• Italy
• Japan
• Portugal
• Singapore
• Slovakia
• Spain
• Sweden
• Taiwan
• United Kingdom

Study Locations