BAY3283142 for Chronic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how a new treatment, BAY3283142, behaves in individuals with chronic kidney disease (CKD). Researchers seek to observe how the treatment moves through the body when liver function is slightly or moderately reduced. Participants will be divided into groups based on liver function to compare results. Suitable candidates have stable liver disease and can identify if they have mild to moderate liver problems. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive it.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants with liver problems can continue taking their other prescribed medicines as usual.
Is there any evidence suggesting that BAY3283142 is likely to be safe for humans?
Researchers are conducting studies to understand the safety of BAY3283142 in people with chronic kidney disease (CKD). Earlier studies tested BAY3283142 to assess its movement through the body and its safety after a single dose. These studies also examined whether individuals with varying liver functions process the drug differently.
The current study is in its early stages (Phase 1) and primarily focuses on safety. Limited information exists on how well people tolerate the drug. Early-phase studies aim to identify any side effects and their severity. Since BAY3283142 is being tested for its effects on individuals with liver function issues, participants are closely monitored for any unwanted side effects.
The goal is to ensure BAY3283142 is safe for people with liver function problems, which is crucial for those with CKD. While this treatment shows promise, researchers are still collecting safety data. Participants receive careful monitoring to ensure their safety as researchers learn more about how the treatment works in the body.12345Why do researchers think this study treatment might be promising for CKD?
Unlike the standard treatments for chronic kidney disease, which often include medications like ACE inhibitors and ARBs, BAY3283142 is a novel therapeutic option that targets a different pathway. Researchers are excited about BAY3283142 because it is designed to tackle the disease at a molecular level, potentially offering a more precise treatment approach. This drug focuses on how the kidneys function and interacts with hepatic impairment, which could lead to better outcomes for patients with varying degrees of liver function. By addressing specific pathways, BAY3283142 holds promise for improved kidney health and patient quality of life.
What evidence suggests that BAY3283142 might be an effective treatment for chronic kidney disease?
Research has shown that BAY3283142 activates a protein called soluble guanylate cyclase (sGC). This protein helps relax blood vessels and may benefit people with chronic kidney disease (CKD). Early results suggest that this treatment can reduce the amount of albumin in the urine, indicating less kidney damage. Ongoing studies aim to better understand its overall impact on kidney function. While initial data appears promising, further research is necessary to fully assess its effectiveness in treating CKD. Participants in this trial will be divided into groups based on hepatic function to evaluate the treatment's impact across different conditions.13567
Are You a Good Fit for This Trial?
This trial is for adults aged 18-79 with chronic kidney disease and confirmed liver problems (mild to moderate), who are not pregnant, agree to use contraception, have stable liver disease, a BMI of 18-36 kg/m2, and can be either gender. Those with severe liver issues or other health conditions that could interfere with the study are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of BAY3283142 and are monitored for pharmacokinetics, safety, and tolerability
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