This study examines people with atherosclerotic cardiovascular disease, chronic kidney disease, and systemic inflammation. Atherosclerotic cardiovascular disease is a condition where fatty deposits build up in the arteries, which can affect blood flow to the heart, brain, or limbs. Chronic kidney disease means the kidneys are not working as well as they should, which affects their ability to filter waste from the blood. Systemic inflammation refers to widespread inflammation in the body that can be measured through blood tests. The study compares the effects of ziltivekimab, an experimental medication given as an injection under the skin once a month, with placebo. Both treatments are given in addition to the usual care that patients receive for their conditions.
The purpose of the study is to see if ziltivekimab works better than placebo in reducing the risk of serious heart-related problems in people who have both cardiovascular disease and kidney disease along with signs of inflammation in their body. The main focus is on preventing major cardiovascular events, which include death from heart-related causes, non-fatal heart attack, and non-fatal stroke. A heart attack occurs when blood flow to part of the heart muscle is blocked, while a stroke happens when blood flow to part of the brain is interrupted.
During the study, participants will receive either ziltivekimab or placebo through regular injections while continuing their standard medical treatment. The study will track various health outcomes over time, including heart attacks, strokes, heart-related deaths, hospital admissions for heart problems, and changes in kidney function. Researchers will also monitor changes in inflammation markers in the blood, heart function measurements, and overall health status. The study will measure how the kidneys are working by looking at blood test results that show the filtering ability of the kidneys and the amount of protein in the urine, which can indicate kidney damage.
1Assignment to treatment group
Upon entering the study, you will be randomly assigned to receive either ziltivekimab or placebo. This assignment is done by chance, similar to flipping a coin.
The placebo looks identical to ziltivekimab but contains no active medication. This helps researchers determine if the study medication is effective.
Both ziltivekimab and placebo will be given in addition to your standard medical care, which means you will continue taking your regular medications as prescribed by your doctor.
2Monthly injections
You will receive injections under the skin (subcutaneous injections) once every month throughout the study.
The medication is provided as a solution for injection, which means it is a liquid ready to be injected.
These monthly injections will continue for the entire duration of the study.
3Regular monitoring visits
During the study, you will attend regular visits where various measurements and tests will be performed.
Blood samples will be taken to measure specific markers in your blood, including hs-CRP (a marker of inflammation in your body), NT-pro-BNP (a marker related to heart function), and haemoglobin (a component of blood that carries oxygen).
Your kidney function will be monitored by measuring eGFR (estimated glomerular filtration rate, which shows how well your kidneys are filtering waste from your blood) and UACR (urine albumin-to-creatinine ratio, which detects protein in your urine).
These measurements will be taken at the beginning of the study and repeated at specific time points, including at 2 years into the study.
4Heart function assessment
Your heart function will be evaluated by measuring left ventricular ejection fraction, which indicates how well the main pumping chamber of your heart is working.
This measurement will be taken at the start of the study and again at 2 years.
5Quality of life assessment
You will be asked to complete a questionnaire called Short Form 36, which assesses your physical health and how it affects your daily activities.
This questionnaire will be completed at the beginning of the study and at 2 years.
6Ongoing health monitoring
Throughout the study, any health events will be recorded, including heart-related events such as heart attack (myocardial infarction), stroke, cardiovascular death (death related to heart or blood vessel problems), hospitalizations for heart failure, and procedures to restore blood flow to the heart or other arteries.
Kidney-related events will also be monitored, including significant decreases in kidney function or the need for kidney replacement therapy (such as dialysis or kidney transplant).
Any episodes of atrial fibrillation (irregular heart rhythm) will be documented.
Hospitalizations or deaths related to infections will be recorded.
All deaths from any cause will be tracked.
7Continuation until study completion
You will continue receiving the monthly injections and attending monitoring visits until the study ends.
The study is expected to continue for several years, and the exact end date will be determined by the research team based on the number of health events observed across all participants.
Who Can Join the Study?
You must have chronic kidney disease, which means your kidneys do not work as well as they should. This can be shown in one of two ways: either your eGFR (a blood test that measures how well your kidneys filter waste) is between 15 and 60, or your UACR (a urine test that measures protein in your urine) is 200 or higher with an eGFR of 60 or above.
Your blood test must show a hs-CRP level of 2 or higher. This measures inflammation in your body, which means there is swelling or irritation inside your body that you may not be able to feel.
You must have atherosclerotic cardiovascular disease, which means you have hardening and narrowing of your blood vessels. This can be shown by having one or more of the following conditions:
You have coronary heart disease, which affects the blood vessels of your heart. This includes having had a heart attack in the past, having had a procedure to open blocked heart arteries, or having at least 50% blockage in a major heart artery shown by special imaging tests.
You have cerebrovascular disease, which affects the blood vessels in your brain and neck. This includes having had a stroke caused by blocked arteries, having had a procedure to open blocked neck arteries, or having at least 50% blockage in a neck artery shown by special imaging tests.
You have symptomatic peripheral artery disease, which affects the blood vessels in your legs and causes symptoms. This includes having leg pain when walking with an ankle-brachial index of 0.90 or less (a test comparing blood pressure in your ankle and arm), having leg pain with at least 50% blockage in leg arteries shown by special imaging tests, having had a procedure to open blocked leg arteries, or having had part of your leg amputated due to blocked arteries.
You must be an adult.
Both men and women can participate in this study.
Who Cannot Join the Study?
The study does not list specific reasons why patients cannot participate in the trial based on the available information
If you have questions about whether you can join this study, your doctor will need to review the complete study requirements with you
General factors that often prevent participation in clinical trials may include having certain other medical conditions, taking specific medications, or having recent surgeries, but these have not been specified for this particular study
Your healthcare provider will determine if you meet all the necessary requirements to safely participate in this research
Ziltivekimab is an investigational medication given as an injection under the skin once a month. It is being tested to see if it can reduce the risk of major heart problems in people who have heart disease, kidney disease, and inflammation in their body. This medication is given in addition to the standard treatments that patients are already receiving for their conditions.
Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against ziltivekimab to help determine if the real medication is working. Patients receiving placebo will also continue to receive their standard care treatments.
Atherosclerotic Cardiovascular Disease – Atherosclerotic cardiovascular disease is a condition where fatty deposits called plaques build up inside the arteries that supply blood to the heart and other parts of the body. These plaques are made up of cholesterol, fat, calcium, and other substances found in the blood. Over time, the plaques harden and narrow the arteries, reducing blood flow to vital organs. As the disease progresses, the plaques can rupture or break open, leading to blood clot formation. This reduced blood flow can cause chest pain, shortness of breath, and may lead to serious events such as heart attacks or strokes. The condition develops gradually over many years and often shows no symptoms in its early stages.
Chronic Kidney Disease – Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste products and excess fluids from the blood. The kidneys become damaged over time due to various factors such as high blood pressure, diabetes, or other underlying health conditions. As the disease progresses, waste products and fluids build up in the body, which can cause various health problems. The kidney function is measured by a value called estimated glomerular filtration rate, which decreases as the disease worsens. In advanced stages, the kidneys may lose most of their filtering ability, requiring medical intervention to remove waste from the blood. The progression of the disease is typically divided into five stages, with stage five being the most severe.
Systemic Inflammation – Systemic inflammation is a condition where the body’s immune system remains activated throughout the entire body rather than just in a specific area. This widespread immune response causes the release of inflammatory substances into the bloodstream that affect multiple organs and tissues. The inflammation persists over time and can be measured through blood tests that detect markers such as C-reactive protein. This ongoing inflammatory state can contribute to damage of blood vessels and organs throughout the body. The condition often occurs alongside other diseases and can worsen their progression. Unlike acute inflammation that resolves quickly, systemic inflammation continues for extended periods and becomes a chronic health issue.
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