clinical trial · NCT05485961
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
CSL Behring·phase3·recruiting·n = 2,310
Atherosclerotic Cardiovascular DiseaseEnd Stage Kidney DiseaseAtherosclerotic Cardiovascular Disease in Patients With ESKDCSL300Placebo
brief summary
This is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.
started
Oct 21, 2022
primary completion
Sep 27, 2029
completion
Sep 27, 2029
last updated
Apr 9, 2026
official title
A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol