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Taking people in ItalyPhase 2/3

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
Bologna, Brescia, Cagliari, Caserta, Catania, Ferrara, Florence, Foggia, Genova, Lecce, Lecco, Messina, Milan, Naples, Novara, Pavia, Peschiera del Garda, Piacenza, Pisana, Prato, Reggio Calabria, Rimini, Roma, Rome, San Giovanni Rotondo, and Verona, ItalySee the 29 sites
Phase
Phase 2/3

Where in Italy

  • Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola MalpighiBologna, ItalyTaking people
  • Asst Degli Spedali Civili Di BresciaBrescia, ItalyTaking people
  • Azienda Ospedaliera BrotzuCagliari, ItalyTaking people
  • Azienda Ospedaliera Sant'Anna E San Sebastiano Di CasertaCaserta, ItalyTaking people
  • AOU Policlinico G Rodolico - San Marco - Presidio Ospedaliero ospedale San MarcoCatania, ItalyTaking people
  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'AnnaFerrara, ItalyNo longer taking part
  • Ospedale Santa Maria AnnunziataFlorence, ItalyTaking people
  • A. O. -Universitaria Ospedali Riuniti di Foggia Farmacia OspFoggia, ItalyTaking people
  • IRCCS Az. Osp. Universitaria San Martino- ISTGenova, ItalyNo longer taking part
  • Vito Fazzi Hospital in LecceLecce, ItalyNo longer taking part
  • ASST di Lecco - Presidio Ospedaliero A. Manzoni di LeccoLecco, ItalyTaking people
  • Università degli Studi di MessinaMessina, ItalyTaking people
  • ASST Great Metropolitan Hospital NiguardaMilan, ItalyTaking people
  • ASST Santi Paolo e Carlo - Ospedale San Carlo BorromeoMilan, ItalyTaking people
  • IRCCS Ospedale San RaffaeleMilan, ItalyNo longer taking part
  • AOU L. Vanvitelli Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
  • Ospedale Maggiore di NovaraNovara, ItalyTaking people
  • ICS Maugeri S.p.A. SB; Università di Pavia; Fondazione Salvatore Maugeri IRCCSPavia, ItalyTaking people
  • University of VeronaPeschiera del Garda, ItalyTaking people
  • AUSL Piacenza Hospital-Unit Nephrology Dialysis, Dept of MedicinePiacenza, ItalyTaking people
  • Azienda Ospedaliero Universitaria Pisana - Ospedale di Cisanello - Stabilimento Ospedaliero di CisanelloPisana, ItalyTaking people
  • Ospedale Santo StefanPrato, ItalyTaking people
  • Grande Ospedale Metropolitano Bianchi Melacrino MorelliReggio Calabria, ItalyTaking people
  • Rimini HospitalRimini, ItalyTaking people
  • Policlinico A. Gemelli UniversitarioRoma, ItalyTaking people
  • Sandro Pertini HospitalRome, ItalyTaking people
  • Azienda Unita Sanitaria Locale (USL) Roma 3 (AUSL RM 3) - Presidio Ospedaliero Giovan Battista GrassiRome, ItalyNo longer taking part
  • Ospedale Casa Sollievo della Sofferenza (CSS)San Giovanni Rotondo, ItalyTaking people
  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo TrentoVerona, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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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.

ClinicalTrials.gov NCT05485961 · EU CTIS 2022-500273-14-00