Grabels

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are evaluating the effects of two hemodialysis methods—high-flux hemodialysis (HD) and hemodiafiltration (HDF)—on fatigue and recovery time after dialysis in patients aged 85 years and older. This randomized, multicenter, crossover clinical trial aims to determine the better dialysis technique for these older patients, as previous studies have suggested HDF may prolong recovery time despite improving survival in younger patients. The study includes two treatment periods of three months each, separated by a two-week washout of traditional low-flux hemodialysis, with each patient serving as their own control. Participants will be randomly assigned to receive either HDF followed by HD or HD followed by HDF, each for three months. Before starting and between the two periods, patients will undergo two weeks of low-flux hemodialysis as a washout phase. The study evaluates the removal of solutes by diffusion (HD) and convection (HDF) during dialysis. Throughout the study, various clinical and laboratory data will be collected, including dialysis parameters, medication use, and residual kidney function. During the 7-month participation, patients will answer questions about their dialysis recovery time and fatigue using validated scales, and perform a muscle performance test after dialysis sessions. Health-related quality of life will also be assessed. Researchers will monitor blood pressure, clotting events, hospital admissions, and deaths. Laboratory tests will be done monthly during each treatment period to evaluate biochemical markers and dialysis adequacy. The primary outcome is the change in dialysis recovery time over three months, with secondary outcomes including fatigue, symptomatic hypotension, clotting events, quality of life, safety, and other clinical measures.