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
- Belo Horizonte, Fortaleza, Goiânia, Joinville, Maringá, Natal, Passo Fundo, Porto Alegre, Praia Do Canto, Ribeirão Preto, Salvador, São José do Rio Preto, and São Paulo, BrazilSee the 23 sites
- Phase
- Phase 2/3
Where in Brazil
- NUPEC-Nucleo de Pesquisa ClinicaBelo Horizonte, BrazilTaking people
- Santa Casa de Misericordia de Belo HorizonteBelo Horizonte, BrazilTaking people
- Hospital Universitário Walter Cantídio (Fortaleza)Fortaleza, BrazilTaking people
- Empresa Brasileira de Serviços Hospitalares (EBSERH)Goiânia, BrazilTaking people
- Fundacao Pro Rim de Santa CatarinaJoinville, BrazilTaking people
- Clipem - Clínica o Pesquisa Endocrinológica de MaringáMaringá, BrazilTaking people
- Instituto Atena de Pesquisa ClínicaNatal, BrazilTaking people
- Hospital de Clinicas de Passo FundoPasso Fundo, BrazilTaking people
- Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilTaking people
- Hospital Sao Lucas da PUCRSPorto Alegre, BrazilTaking people
- Irmandade Santa Casa de Misericordia de Porto AlegrePorto Alegre, BrazilTaking people
- CEDOES - Centro de Diagnostico e PesquisaPraia Do Canto, BrazilTaking people
- SERVIÇO DE NEFROLOGIA DE RIBEIRÃO Preto (SENERP)Ribeirão Preto, BrazilTaking people
- Universidade de Sao Paulo (USP)-Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto (HCFMRP)Ribeirão Preto, BrazilTaking people
- Clinica Senhor do Bonfim Ltda (CSB) - Monte SerratSalvador, BrazilTaking people
- Secretaria da Saúde do Estado da Bahia (SESAB)Salvador, BrazilTaking people
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio PretoSão José do Rio Preto, BrazilTaking people
- Hospital 9 de JulhoSão Paulo, BrazilTaking people
- Hospital Alemão Oswaldo CruzSão Paulo, BrazilTaking people
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São PauloSão Paulo, BrazilTaking people
- Hospital do Rim e HipertensãoSão Paulo, BrazilTaking people
- Hospital Santa MarcelinaSão Paulo, BrazilTaking people
- Trialstar-Centro de Pesquisa ClinicasSão Paulo, BrazilTaking 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.