Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522997
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
Sponsor:
None
Organization:
None
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALPINE 1
Brief 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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None