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
CSL Behring
Summary
This is a two-part, phase 2b and phase 3 combined 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 vs placebo 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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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. * Part 1 (Phase 2b) excludes subjects with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of subjects with a latent TB and at least 4 weeks of prophy…
Interventions
- DrugCSL300
IV administration
- DrugPlacebo
Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.
Locations (557)
- Nephrology of North AlabamaDecatur, Alabama
- Nephrology Consultants, LLCHuntsville, Alabama
- DaVita Clinical Research MontgomeryMontgomery, Alabama
- AKDHC MedicalGlendale, Arizona
- Kidney Disease Medical GroupGlendale, Arizona
- AKDHC MedicalPhoenix, Arizona