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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: End Stage Kidney Disease

In brief

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.

Key facts

Study ID

NCT05485961

Run by

CSL Behring

People needed

3110

Starts

2022-10-21

Expected to finish

2029-05-22

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Nephrology of North Alabama — Decatur, Alabama, United States (enrolling)
• DaVita Clinical Research Montgomery — Montgomery, Alabama, United States (enrolling)
• AKDHC Medical — Glendale, Arizona, United States (enrolling)
• Nephrology Consultants, LLC — Huntsville, Alabama, United States (enrolling)
• AKDHC Medical — Phoenix, Arizona, United States (enrolling)
• AKDHC Medical — Tucson, Arizona, United States (enrolling)
• Southern Arizona VA Health Care System — Tucson, Arizona, United States (enrolling)
• National Institute of Clinical Research — Bakersfield, California, United States (enrolling)
• Kidney Disease Medical Group — Glendale, Arizona, United States (enrolling)
• California Institute of Renal Research — Chula Vista, California, United States (enrolling)
• The Medical Research Group, Inc. — Fresno, California, United States (enrolling)
• Davita Fullerton Dialysis Center — Fullerton, California, United States (enrolling)
• National Institute of Clinical Research, Inc. — Fullerton, California, United States (enrolling)
• National Institute of Clinical Research, Inc. — Garden Grove, California, United States (enrolling)
• St. Jude Medical Center — Garden Grove, California, United States (enrolling)
• National Institute of Clinical Research — Garden Grove, California, United States (enrolling)
• Sherman Medical Group, Inc — Glendale, California, United States (enrolling)
• Kidney Disease Medical Group — Glendale, California, United States (enrolling)
• Renal Consultants Medical Group — Granada Hills, California, United States (enrolling)
• Balboa Research — La Jolla, California, United States (enrolling)
• California Institute of Renal Research — La Mesa, California, United States (enrolling)
• Southern California Medical Research Center — La Palma, California, United States (enrolling)
• Academic Medical Research Institute — Los Angeles, California, United States (enrolling)
• National Institute of Clinical Research, Inc. — Los Angeles, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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