Grabels

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.

Researchers are comparing two common hemodialysis methods, high-flux hemodialysis HD and hemodiafiltration HDF, to understand their effects on fatigue and recovery time after dialysis in patients aged 85 years and older. This randomized, multicenter, crossover trial aims to clarify which dialysis technique is better for older patients, as previous studies showed mixed results regarding recovery time with HDF in this age group. The study is designed to have each patient experience both treatments over separate periods for direct comparison. Participants will be randomly assigned to one of two sequences either three months of HD followed by three months of HDF or vice versa. Between these treatment periods, there will be two weeks of traditional low-flux hemodialysis to act as a washout. Treatments are administered three times a week, with sessions lasting 3.5 to 4 hours. Various dialysis parameters and medication details are recorded throughout the study to monitor the treatments. During the 7-month participation, patients will undergo multiple assessments including dialysis recovery time, fatigue levels using the SONG-fatigue scale, muscle performance via the stand-to-sit test, and quality of life through the SF-12 survey. Laboratory tests, blood pressure, and clinical events like hypotension and clotting are tracked regularly. Hospitalizations and mortality are also monitored to evaluate safety. Data are collected at screening, during both treatment periods, and follow-up visits, ensuring thorough monitoring of patient outcomes.