A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease (ALPINE 1)

Bayer

Status and phase: Enrolling; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: BAY3283142; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06522997

2023-505755-40-00 (Registry Identifier)

22040

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 laboratory values is allowed during the Screening period"
• UACR ≥200 mg/g and <3500 mg/g as determined by the geometric mean (as calculated by the central laboratory) of 3 morning void urine specimens obtained at Screening
• Treatment with the highest tolerated labeled dose of either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB), unless such treatment is either not tolerated or contraindicated. Treatment dose must be stable dose for at least 4 weeks before Screening with no planned change of the therapy during 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 criteria

• Systolic blood pressure (SBP) <100 mmHg at Visit 2 (baseline)
• Patients with a tendency for clinically relevant orthostatic hypotension at Screening and Visit 2 (baseline) as judged by the investigator
• SBP ≥160 mmHg, unless treated with ≥3 blood pressure lowering medications, at Screening or at Visit 2 (baseline)
• History of secondary hypertension other than CKD
• Hepatic impairment corresponding to Child-Pugh B or C or other significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g. AST or ALT >3x ULN or total bilirubin >2x ULN) at Screening
• Polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis and any other kidney disease requiring immunosuppressive therapy within 6 months prior to Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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700 participants in 6 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

Placebo OD and sham titration after 14 days and after 28 days

Treatment:

Drug: Placebo

Arm 2

Experimental group

Description:

BAY3283142 (dose 1) OD and sham titration after 14 days and after 28 days

Treatment:

Drug: BAY3283142

Arm 3

Experimental group

Description:

BAY3283142 (dose 2) OD and sham titration after 14 days and after 28 days

Treatment:

Drug: BAY3283142

Arm 4

Experimental group

Description:

BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and sham titration after 28 days

Treatment:

Drug: BAY3283142

Arm 5

Experimental group

Description:

BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and to dose 4 OD after 28 days

Treatment:

Drug: BAY3283142

Arm 6

Experimental group

Description:

BAY3283142 (dose 3) OD and uptitration to dose 5 OD after 14 days and sham titration after 28 days

Treatment:

Drug: BAY3283142