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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.

Key facts

Who runs it
CSL Behring
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 sitesAlso in 34 other countries, 532 sites
Registry title
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
Status
Recruiting
Phase
Phase 2/3
People taking part
3,110 people, planned
Started
27 Apr 2024
Expected to end
22 May 2029
Type of study
Interventional, 6 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • CSL300
  • Placebo
Record updated
21 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with end stage kidney disease who have been on regular dialysis for at least 12 weeks. They need signs of inflammation and either diabetes or atherosclerotic heart and blood vessel disease.

Age
18 years or older
Sex
Men and women can join.
Disease stage
End stage kidney disease on maintenance dialysis for at least 12 weeks, with diabetes mellitus or atherosclerotic cardiovascular disease (ASCVD).
Earlier treatment
Dialysis for at least 12 weeks. People who took part in Part 1 (phase 2b) cannot join Part 2 (phase 3).
Biomarker or test result
Serum hs-CRP of 2.0 mg/L or higher.

Main reasons for not taking part

  • Took part in Part 1 (phase 2b) and now wants to join Part 2 (phase 3)
  • Taking systemic immunosuppressant drugs
  • Positive TB test or past latent TB (Part 1); active TB (Part 2)
  • Abnormal liver function tests
  • Life-threatening disease expected to cause death within 12 months

This trial only enrols participants on dialysis. The registry sentence this rests on: A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks.

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Italy

Also in 34 other countries, 532 sites

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

About the trial

What the trial wants to find out

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

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.

The 6 groups in the trial

  • CSL300 (low dose)(Phase 2b)Treatment being tested

    Intravenous (IV) administration

    Treatment: CSL300

  • CSL300 (medium dose)(Phase 2b)Treatment being tested

    IV administration

    Treatment: CSL300

  • CSL300 (high dose)(Phase 2b)Treatment being tested

    IV administration

    Treatment: CSL300

  • Placebo (Phase 2b)Placebo, for comparison

    IV administration

    Treatment: Placebo

  • CSL300 (Phase 3)Treatment being tested

    IV administration

    Treatment: CSL300

  • Placebo (Phase 3)Placebo, for comparison

    IV administration

    Treatment: Placebo

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?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests clazakizumab in adults with kidney failure on dialysisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 September 2026