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Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)

NCT05485961

RecruitingPhase 2, Phase 3

Sponsor: CSL Behring

Conditions: End Stage Kidney Disease

Interventions: CSL300, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 prophylactic TB treatment.
* 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.
Locations (557)
  • Decatur, Alabama, United States
  • Huntsville, Alabama, United States
  • Montgomery, Alabama, United States
  • Glendale, Arizona, United States
  • Glendale, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Bakersfield, California, United States
  • Beverly Hills, California, United States
  • Chula Vista, California, United States
  • Fresno, California, United States
  • Fullerton, California, United States
  • Fullerton, California, United States
  • Garden Grove, California, United States
  • Garden Grove, California, United States
  • Garden Grove, California, United States
  • Glendale, California, United States
  • Glendale, California, United States
  • Granada Hills, California, United States
  • La Jolla, California, United States
  • La Mesa, California, United States
  • La Palma, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Lynwood, California, United States
  • Northridge, California, United States
  • Oxnard, California, United States
  • + 527 more on CT.gov