Status:
RECRUITING
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
Lead Sponsor:
CSL Behring
Conditions:
Atherosclerotic Cardiovascular Disease
End Stage Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 (pha...
Eligibility Criteria
Inclusion
- \- 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
- \- 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
Key Trial Info
Start Date :
October 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 27 2029
Estimated Enrollment :
2310 Patients enrolled
Trial Details
Trial ID
NCT05485961
Start Date
October 21 2022
End Date
September 27 2029
Last Update
March 2 2026
Active Locations (468)
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1
Nephrology of North Alabama
Decatur, Alabama, United States, 35601
2
Nephrology Consultants, LLC
Huntsville, Alabama, United States, 35805
3
DaVita Clinical Research Montgomery
Montgomery, Alabama, United States, 36117
4
AKDHC Medical
Glendale, Arizona, United States, 85305