BAY3283142 for Chronic Kidney Disease
(ALPINE 1 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications. In fact, you need to continue taking your standard treatment for CKD and other conditions like high blood pressure and diabetes at a stable dose for at least 4 weeks before starting the study.
What is the purpose of this trial?
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 studyPeople 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
This trial is for adults over 18 with chronic kidney disease (CKD), specifically those with reduced kidney function and high levels of albumin in their urine. Participants should be on a stable dose of medication for managing blood pressure, diabetes, or kidney conditions for at least 4 weeks prior to the study. People with low blood pressure, recent severe cardiovascular events, serious liver disease, or who require immune system-controlling drugs for kidney issues cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BAY3283142 or placebo for 16 weeks, with dose adjustments at specified intervals
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BAY3283142
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD