Last updated 6 days ago
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
2310 patients around the world
Available in Argentina, United States, Brazil
CSL Behring
4Research sites
2310Patients around the world
This study is for people with
Renal disease
End-stage renal disease
Cardiovascular disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Fresenius Medical Care Formosa
Recruiting
Cendial - Centro de Nefrología y Diálisis S.A.
Recruiting
Instituto de Diálisis Fresenius Mansilla
Recruiting
Centro de Diálisis Fresenius Medical Care Argentina S.A. - Tucumán
Recruiting
StudyPOSIBIL6ESKD
SponsorCSL Behring
Study typeInterventional
Conditions
End-stage renal diseaseCardiovascular disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05485961
