Comuna 12

This research aims to evaluate the safety and effectiveness of sodium-glucose cotransporter 2 inhibitors SGLT2i in patients with end-stage kidney disease undergoing maintenance hemodialysis. Cardiovascular complications such as heart failure, arrhythmias, and sudden cardiac death are common in this group, often linked to diastolic dysfunction and cardiac fibrosis that current treatments do not adequately address. This Phase 2 randomized controlled trial seeks to determine if SGLT2 inhibitors can improve cardiac function and reduce these risks. Participants will be randomly assigned to one of two groups one receiving standard hemodialysis care without SGLT2 inhibitors, and the other receiving a once-daily oral SGLT2 inhibitor alongside standard care for 12 months. The intervention group will be monitored through advanced cardiac imaging and biomarker assessments at baseline and at 3, 6, and 12 months. The study will assess changes in heart structure and function, myocardial fibrosis, and the frequency of intradialytic hypotension. Throughout the 12-month study, participants will undergo comprehensive evaluations including echocardiography, cardiac MRI, 24-hour heart rhythm monitoring, and laboratory tests. Researchers will track cardiovascular events, hospitalizations, and mortality. Data will be collected at multiple time points to measure outcomes such as changes in left ventricular mass and ejection fraction, fibrosis biomarkers, and incidence of hypotension during dialysis. This thorough monitoring aims to provide new insights into cardiac health in dialysis patients.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.