BAY3283142 for Chronic Kidney Disease
(ALPINE 1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve chronic kidney disease (CKD) treatment by testing a new drug, BAY3283142. The drug relaxes blood vessels, potentially improving kidney function by reducing urine albumin, a common CKD issue. Participants will take either BAY3283142 or a placebo, alongside their usual CKD treatments, for 16 weeks. Those with CKD, poor kidney function, high urine albumin levels, and conditions like high blood pressure or diabetes may qualify. The study will assess whether BAY3283142 can become a new CKD treatment option. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.
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.
Is there any evidence suggesting that BAY3283142 is likely to be safe for humans?
Research has shown that BAY3283142 is being tested for safety in people with chronic kidney disease (CKD). Early studies administered the drug in single and multiple doses to assess its effects and safety in the body.
Initial results suggest that BAY3283142 is generally well-tolerated. Some side effects, such as headaches and mild stomach discomfort, were reported but were mostly mild. No serious side effects were commonly linked to the drug in these studies.
As this is a new treatment under investigation, researchers are closely monitoring its safety. They aim to ensure that any side effects remain manageable and do not outweigh the potential benefits for people with CKD. Participants in the trial will undergo regular medical check-ups to detect and manage any issues promptly.12345Why do researchers think this study treatment might be promising for CKD?
Researchers are excited about BAY3283142 for chronic kidney disease because it offers a novel approach compared to current treatments like ACE inhibitors or ARBs. BAY3283142 works differently by targeting specific pathways involved in kidney function, potentially providing more precise control over disease progression. Unlike standard medications, which might take longer to adjust and show effects, BAY3283142 has a structured dosing plan that could allow for quicker adjustments and more immediate results. This unique mechanism and flexible dosing could make a significant impact on managing chronic kidney disease more effectively.
What evidence suggests that BAY3283142 might be an effective treatment for chronic kidney disease?
Research has shown that BAY3283142 might help treat chronic kidney disease (CKD) by activating a protein that relaxes blood vessels, potentially benefiting kidney health. Early studies suggest that BAY3283142 could reduce the amount of protein, particularly albumin, lost in urine, a common issue in CKD. The treatment aims to slow the decline in kidney function by addressing albuminuria, a major concern in CKD. Although researchers are still studying the treatment, its approach shows promise in improving kidney health for CKD patients. Participants in this trial will receive varying doses of BAY3283142 or a placebo to evaluate its effectiveness and safety.13567
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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