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

NCT05485961 · tracked via the Priya Life Science UK tracker

Sponsor

CSL Behring

Phase

Phase 2/3

Started

2022-10-21

Last updated

2026-08-11

Condition(s) studied

End Stage Kidney Disease

Investigational drug(s) / intervention(s)

CSL300Placebo

CSL300: IV administration

Placebo: Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b) — Baseline and up to Week 12
Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3) — Approximately 5 years

Trial sites (557)

Facility	City	Region	Status
Nephrology of North Alabama	Decatur	Alabama	Recruiting
Nephrology Consultants, LLC	Huntsville	Alabama	Recruiting
DaVita Clinical Research Montgomery	Montgomery	Alabama	Recruiting
AKDHC Medical	Glendale	Arizona	Recruiting
Kidney Disease Medical Group	Glendale	Arizona	Recruiting
AKDHC Medical	Phoenix	Arizona	Recruiting
AKDHC Medical	Tucson	Arizona	Recruiting
Southern Arizona VA Health Care System	Tucson	Arizona	Recruiting
National Institute of Clinical Research	Bakersfield	California	Recruiting
Amicis Research Center	Beverly Hills	California	Withdrawn
California Institute of Renal Research	Chula Vista	California	Recruiting
The Medical Research Group, Inc.	Fresno	California	Recruiting
Davita Fullerton Dialysis Center	Fullerton	California	Recruiting
National Institute of Clinical Research, Inc.	Fullerton	California	Recruiting
National Institute of Clinical Research, Inc.	Garden Grove	California	Recruiting
St. Jude Medical Center	Garden Grove	California	Recruiting
National Institute of Clinical Research	Garden Grove	California	Recruiting
Sherman Medical Group, Inc	Glendale	California	Recruiting
Kidney Disease Medical Group	Glendale	California	Recruiting
Renal Consultants Medical Group	Granada Hills	California	Recruiting
Balboa Research	La Jolla	California	Recruiting
California Institute of Renal Research	La Mesa	California	Recruiting
Southern California Medical Research Center	La Palma	California	Recruiting
Academic Medical Research Institute	Los Angeles	California	Recruiting
National Institute of Clinical Research, Inc.	Los Angeles	California	Recruiting
DaVita Carabello Dialysis Center	Los Angeles	California	Suspended
Cedars-Sinai Medical Center	Los Angeles	California	Recruiting
Renal Medical Associates/NARI	Lynwood	California	Recruiting
Amicis Research Center	Northridge	California	Recruiting
FORMAT Medical Research	Oxnard	California	Recruiting
National Institute of Clinical Research, Inc.	Pomona	California	Recruiting
Van Buren Dialysis Center	Riverside	California	Recruiting
National Nephrology Alliance Research - Riverside	Riverside	California	Recruiting
Central Coast Nephrology Medical Corp	Salinas	California	Recruiting
California Institute of Renal Research	San Diego	California	Recruiting
California Institute of Renal Research	San Diego	California	Suspended
North America Research Institute	San Dimas	California	Recruiting
Satellite Healthcare	San Jose	California	Suspended
Nephrology Educational Services	Tarzana	California	Recruiting
Valiance Clinical Research	Tarzana	California	Recruiting

+ 517 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05485961 on ClinicalTrials.gov ↗ ← All trials in the UK