NCT05485961

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,310 (estimated)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerotic Cardiovascular Disease
• End Stage Kidney Disease
• Atherosclerotic Cardiovascular Disease in Patients With ESKD

Interventions

Type	Name	Description
DRUG	CSL300	IV administration
DRUG	Placebo	Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.

Timeline

• Start date: 2022-10-21
• Primary completion: 2029-09-27
• Completion: 2029-09-27
• First posted: 2022-08-03
• Last updated: 2026-04-09

Locations

538 sites across 33 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Norway, Poland, Portugal, Puerto Rico, Romania, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study