ALPINE-1
Research type
Research Study
Full title
A Phase 2b dose-finding, randomized, placebo-controlled, double-blind study to evaluate efficacy and safety of BAY 3283142 on top of standard of care in reducing albuminuria in patients with chronic kidney disease.
IRAS ID
1009777
Contact name
Alexandra Kley
Contact email
Sponsor organisation
Bayer AG
Research 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 & diabetes are more likely to have CKD & 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.
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 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.
Participants may or may not get the expected benefits of treatment with BAY3283142, but they will receive thorough medical check-ups during this study.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
24/EE/0093
Date of REC Opinion
13 Jun 2024
REC opinion
Further Information Favourable Opinion