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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,222
- 试验地点
- 272
- 主要终点
- Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In this double-blind study, participants will be randomly assigned to receive study intervention. Investigators, participants and study personnel will remain blinded to each participant's assigned study intervention throughout the course of the study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥18 years of age
- •eGFR (Chronic Kidney Disease Epidemiology Collaboration formula) ≥20 and ≤75 mL/min /1.73 m^2 at Screening Note: One re-assessment of eGFR based on central laboratory values is allowed during the Screening period"
- •UACR ≥200 mg/g and <3500 mg/g as determined by the geometric mean (as calculated by the central laboratory) of 3 morning void urine specimens obtained at Screening
- •Treatment with the highest tolerated labeled dose of either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB), unless such treatment is either not tolerated or contraindicated. Treatment dose must be stable dose for at least 4 weeks before Screening with no planned change of the therapy during the study
- •If the participant receives any of the following treatments it should be stable for 4 weeks prior to Screening: sodium-glucose co-transporter-2 (SGLT2) inhibitor, finerenone, diuretics, endothelin-receptor antagonists, or glucagon-like peptide (GLP) receptor agonist
排除标准
- •Systolic blood pressure (SBP) <100 mmHg at Visit 2 (baseline)
- •Patients with a tendency for clinically relevant orthostatic hypotension at Screening and Visit 2 (baseline) as judged by the investigator
- •SBP ≥160 mmHg, unless treated with ≥3 blood pressure lowering medications, at Screening or at Visit 2 (baseline)
- •History of secondary hypertension other than CKD
- •Hepatic impairment corresponding to Child-Pugh B or C or other significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g. AST or ALT >3x ULN or total bilirubin >2x ULN) at Screening
- •Polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis and any other kidney disease requiring immunosuppressive therapy within 6 months prior to Screening
研究组 & 干预措施
Arm 1
Placebo OD and sham titration after 14 days and after 28 days
干预措施: Placebo (Drug)
Arm 2
BAY3283142 (dose 1) OD and sham titration after 14 days and after 28 days
干预措施: BAY3283142 (Drug)
Arm 4
BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and sham titration after 28 days
干预措施: BAY3283142 (Drug)
Arm 3
BAY3283142 (dose 2) OD and sham titration after 14 days and after 28 days
干预措施: BAY3283142 (Drug)
Arm 6
BAY3283142 (dose 3) OD and uptitration to dose 5 OD after 14 days and sham titration after 28 days
干预措施: BAY3283142 (Drug)
Arm 5
BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and to dose 4 OD after 28 days
干预措施: BAY3283142 (Drug)
结局指标
主要结局
Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)
时间窗: From baseline to Week 16
次要结局
- Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to permanent discontinuation of study intervention(From the first dose of study intervention up to 7 days after last intake of study intervention, up to 17 Weeks per each participant)
- Change from baseline over time in estimated glomerular filtration rate (eGFR)(From baseline to Week 16)
- Change from baseline over time in the logarithm of UACR(From baseline to Week 16)