Gallup

Researchers are evaluating AP301, a novel iron-based phosphate binder, in patients with chronic kidney disease who are receiving maintenance dialysis and have elevated blood phosphate levels. This phase 3, randomized, double-blind study aims to determine whether AP301 lowers blood phosphate and how it affects serum calcium, calcium times phosphate, and intact parathyroid hormone levels. The trial also assesses any discomfort or medical problems during treatment and its impact on quality of life in Chinese patients. Participants will first stop all phosphate-lowering medications. They will then take either AP301 or a low-dose comparator (considered ineffective) three times daily for 8 weeks. Following this, all participants receive AP301 three times daily for 24 weeks, with dose adjustments based on blood phosphate levels and physician judgment. Finally, participants will take either AP301 or the comparator three times daily for 3 weeks. Additional treatments may be given if blood phosphate levels become too high or low. During the study, participants will undergo regular assessments including blood tests to monitor serum phosphate, calcium, and parathyroid hormone levels. Electrocardiogram tests will measure changes in QT intervals. Safety is monitored by tracking adverse events throughout the trial, which lasts up to 37 weeks. The primary outcome is the change in serum phosphate concentration from baseline to the end of week 8, with ongoing evaluations over the entire study period.

Researchers are conducting a combined phase 2b and phase 3 study to evaluate the drug CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) who are undergoing dialysis. The study focuses on participants with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The trial aims to find the best dose of CSL300 and then assess its effects on cardiovascular outcomes and safety compared to a placebo. The study is divided into two parts: Part 1 (phase 2b) is a dose-finding phase where different doses of CSL300 are given intravenously to participants to determine the optimal dose versus placebo. Part 2 (phase 3) evaluates the efficacy and safety of the selected CSL300 dose compared to placebo over approximately five years. All treatments are administered by intravenous infusion. Participants will be involved in regular assessments including blood tests to measure inflammation markers such as high-sensitivity C-reactive protein (hs-CRP), cardiovascular events tracking, and monitoring for adverse events. The phase 2b portion includes up to 24 weeks of follow-up for dose evaluation, while the phase 3 portion monitors cardiovascular outcomes like heart attacks or cardiovascular death over about five years. Safety and drug levels in the blood will also be closely observed throughout the study.