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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female at least 18 years of age - A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks - Serum hs-CRP ≥ 2.0 mg/L - A diagnosis of diabetes mellitus OR ASCVD

Exclusion Criteria

  • Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3) - Concomitant use of systemic immunosuppressant drugs - Abnormal LFTs - Any life-threatening disease expected to result in death within 12 months - A history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease - Clinically significant active infection or history of opportunistic or invasive fungal infection

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CSL300 (low dose)(Phase 2b) 		Intravenous (IV) administration
  • Drug: CSL300
    IV administration
    Other names:
    • Clazakizumab
Experimental
CSL300 (medium dose)(Phase 2b) 		IV administration
  • Drug: CSL300
    IV administration
    Other names:
    • Clazakizumab
Experimental
CSL300 (high dose)(Phase 2b) 		IV administration
  • Drug: CSL300
    IV administration
    Other names:
    • Clazakizumab
Placebo Comparator
Placebo (Phase 2b) 		IV administration
  • Drug: Placebo
    0.9% w/v NaCl
Experimental
CSL300 (Phase 3) 		IV administration
  • Drug: CSL300
    IV administration
    Other names:
    • Clazakizumab
Placebo Comparator
Placebo (Phase 3) 		IV administration
  • Drug: Placebo
    Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.

Recruiting Locations

84000220 - Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Trial Information Contact
617-724-8839
hbouchouari@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
CSL Behring

Study Contact

Trial Registration Coordinator
+1 610-878-4697
clinicaltrials@cslbehring.com