This clinical trial is focused on studying the effects of a medication called Clazakizumab in patients with End Stage Kidney Disease (ESKD) who are undergoing dialysis. ESKD is a condition where the kidneys can no longer function properly, and dialysis is a treatment that helps to remove waste and excess fluid from the blood. The study aims to explore how different doses of Clazakizumab, given as an injection, can help reduce inflammation in the body, which is measured by a substance in the blood called high-sensitivity C-reactive protein (hs-CRP). Inflammation is a common issue in patients with ESKD and can lead to other health problems, including heart disease.
The trial will compare the effects of Clazakizumab with a placebo, which is a substance that looks like the medication but does not contain the active ingredient. The study will also use a saline solution, which is a simple saltwater solution, as part of the trial process. The purpose of the study is to determine the best dose of Clazakizumab that can effectively reduce inflammation and to assess its safety in patients with ESKD. Participants will receive the medication or placebo through an intravenous injection, which means it is given directly into a vein.
Throughout the study, researchers will monitor the participants’ health and track any changes in their condition. The study will also look at the impact of Clazakizumab on cardiovascular health, which refers to the health of the heart and blood vessels. This is important because patients with ESKD are at a higher risk of developing heart-related issues. The trial is designed to provide valuable information on how Clazakizumab can help manage inflammation and improve overall health outcomes for patients with ESKD undergoing dialysis.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of end-stage kidney disease (ESKD), and current dialysis treatment.
Blood tests are performed to measure high-sensitivity C-reactive protein (hs-CRP) levels, which must be equal to or greater than 2.0 mg/L. A diagnosis of diabetes mellitus or atherosclerotic cardiovascular disease (ASCVD) is also required.
2randomization
Participants are randomly assigned to receive either the study medication, clazakizumab, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
3treatment administration
The study medication, clazakizumab, is administered as a solution for injection through an intravenous route. The dosage and frequency are determined by the study protocol and may vary as part of the dose-finding phase.
The treatment continues over a specified period, with regular monitoring to assess its effects and any side effects.
4regular monitoring
Throughout the trial, regular visits are scheduled to monitor health status and response to the treatment. This includes blood tests to measure changes in hs-CRP and other markers.
Participants are observed for any adverse events or side effects, which are documented and addressed as necessary.
5follow-up assessments
At the end of the treatment period, follow-up assessments are conducted to evaluate the overall impact of the medication on cardiovascular outcomes and other health indicators.
The primary focus is on changes in hs-CRP levels and the time to first occurrence of cardiovascular events such as heart attack or cardiovascular death.
6study completion
Upon completion of the study, participants receive a final evaluation. This includes a review of all collected data and any remaining health concerns.
Participants are informed about the next steps and any potential continuation of care or follow-up studies.
Who Can Join the Study?
Must be a male or female who is at least 18 years old.
Must have a diagnosis of ESKD (End-Stage Kidney Disease) and be undergoing maintenance dialysis for at least 12 weeks.
Must have a blood test showing serum hs-CRP (high-sensitivity C-reactive protein) level of 2.0 mg/L or higher. This is a marker of inflammation in the body.
Must have a diagnosis of diabetes mellitus (a condition where blood sugar levels are too high) ORASCVD (Atherosclerotic Cardiovascular Disease, which affects the heart and blood vessels).
Who Cannot Join the Study?
Patients who are not diagnosed with atherosclerotic cardiovascular disease and ESKD (End-Stage Kidney Disease) cannot participate.
Patients who are not undergoing maintenance dialysis cannot participate. Maintenance dialysis is a regular treatment that removes waste and excess fluid from the blood when the kidneys are not working properly.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.
CSL300 (Clazakizumab) is a medication being studied for its potential to help people with end-stage kidney disease who are on dialysis. This medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The main goal of using Clazakizumab in this trial is to see if it can lower levels of a protein in the blood called hs-CRP. High levels of hs-CRP are often linked to inflammation and can be a risk factor for heart problems. By reducing hs-CRP, Clazakizumab might help improve heart health in patients undergoing dialysis.
Atherosclerotic Cardiovascular Disease in Patients with End-Stage Kidney Disease – Atherosclerotic cardiovascular disease is characterized by the buildup of fatty deposits, known as plaques, within the walls of arteries. This process leads to the narrowing and hardening of the arteries, which can restrict blood flow. In patients with end-stage kidney disease, this condition is often exacerbated due to factors like chronic inflammation and altered lipid metabolism. Over time, the reduced blood flow can lead to complications such as heart attacks or strokes. The progression of the disease is influenced by the severity of kidney dysfunction and the presence of other risk factors like hypertension and diabetes. Regular monitoring and management of cardiovascular risk factors are crucial in these patients to slow the progression of the disease.
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