Tests clazakizumab in adults with kidney failure on dialysis
Tests clazakizumab against placebo in dialysis patients with heart disease or diabetes and inflammation.
Plain-language title generated from the registry record
Registry title: Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
Key facts
- Where
- Brasov, Bucharest, Cluj-Napoca, Constanța, Craiova, Deva, Iași, Oradea, Ploieşti, Satu Mare, and Târgu Mureş, RomaniaSee the 18 sites
- Phase
- Phase 2/3
Where in Romania
- Centrul de Dializa Fresenius NephroCare BrasovBrasov, RomaniaTaking people
- Centrul de Dializa Fresenius NephroCare BucarestiBucharest, RomaniaTaking people
- Centrul de Nefrologie si Dializa Diaverum FundeniBucharest, RomaniaTaking people
- Centrul de Nefrologie si Dializa DIAVERUM Sema ParcBucharest, RomaniaTaking people
- Centrul De Nefrologie si Dializa DIAVERUM SPLAIBucharest, RomaniaTaking people
- Fundeni Clinical InstituteBucharest, RomaniaTaking people
- SC International Healthcare Systems SA - IHS Sf. Ioan Dialysis CenterBucharest, RomaniaTaking people
- Institutul National de Diabet, Nutriţie şi Boli Metabolice - Prof. Dr. N. Paulescu - CentralBucharest, RomaniaNo longer taking part
- Centrul de Dializa Fresenius NephroCare ClujCluj-Napoca, RomaniaTaking people
- Centrul de Dializa Fresenius NephroCare ConstantaConstanța, RomaniaTaking people
- Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta (Emergency Clinic Hospital Constanta)Constanța, RomaniaTaking people
- Centrul de Nefrologie si Dializa Diaverum CraiovaCraiova, RomaniaTaking people
- Spitalul Judetean de Urgenta DevaDeva, RomaniaTaking people
- Spitalul Clinic -Dr. C.I. Parhon - IasiIași, RomaniaTaking people
- Spitalul Clinic Municipal "Dr. Gavril Curteanu" OradeaOradea, RomaniaTaking people
- Centrul de Dializa Fresenius NephroCare PloiestiPloieşti, RomaniaTaking people
- Spital Judetean De Urgenta Satu MareSatu Mare, RomaniaTaking people
- Centrul Medical de Nefrologie si Dializa Diaverum Targu MuresTârgu Mureş, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CSL Behring
- Trial code
- NCT05485961EU 2022-500273-14-00
- Record updated
- 21 September 2026
- Original description
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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; Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3); Abnormal LFTs.