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Taking people in RomaniaPhase 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
Brasov, Bucharest, Cluj-Napoca, Constanța, Craiova, Deva, Iași, Oradea, Ploieşti, Satu Mare, and Târgu Mureş, RomaniaSee the 18 sitesAlso in 34 other countries, 543 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 Romania

Also in 34 other countries, 543 sites

  • Centrul de Dializa Fresenius NephroCare BrasovBrasov, RomaniaContact: Trial Registration CoordinatorTaking people
  • Centrul de Dializa Fresenius NephroCare BucarestiBucharest, RomaniaContact: Trial Registration CoordinatorTaking people
  • Centrul de Nefrologie si Dializa Diaverum FundeniBucharest, RomaniaContact: Trial Registration CoordinatorTaking people
  • Centrul de Nefrologie si Dializa DIAVERUM Sema ParcBucharest, RomaniaContact: Trial Registration CoordinatorTaking people
  • Centrul De Nefrologie si Dializa DIAVERUM SPLAIBucharest, RomaniaContact: Trial Registration CoordinatorTaking people
  • Fundeni Clinical InstituteBucharest, RomaniaContact: Trial Registration CoordinatorTaking people
  • SC International Healthcare Systems SA - IHS Sf. Ioan Dialysis CenterBucharest, RomaniaContact: Trial Registration CoordinatorTaking people
  • Institutul National de Diabet, Nutriţie şi Boli Metabolice - Prof. Dr. N. Paulescu - CentralBucharest, RomaniaContact: Trial Registration CoordinatorNo longer taking part
  • Centrul de Dializa Fresenius NephroCare ClujCluj-Napoca, RomaniaContact: Trial Registration CoordinatorTaking people
  • Centrul de Dializa Fresenius NephroCare ConstantaConstanța, RomaniaContact: Trial Registration CoordinatorTaking people
  • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta (Emergency Clinic Hospital Constanta)Constanța, RomaniaContact: Trial Registration CoordinatorTaking people
  • Centrul de Nefrologie si Dializa Diaverum CraiovaCraiova, RomaniaContact: Trial Registration CoordinatorTaking people
  • Spitalul Judetean de Urgenta DevaDeva, RomaniaContact: Trial Registration CoordinatorTaking people
  • Spitalul Clinic -Dr. C.I. Parhon - IasiIași, RomaniaContact: Trial Registration CoordinatorTaking people
  • Spitalul Clinic Municipal "Dr. Gavril Curteanu" OradeaOradea, RomaniaContact: Trial Registration CoordinatorTaking people
  • Centrul de Dializa Fresenius NephroCare PloiestiPloieşti, RomaniaContact: Trial Registration CoordinatorTaking people
  • Spital Judetean De Urgenta Satu MareSatu Mare, RomaniaContact: Trial Registration CoordinatorTaking people
  • Centrul Medical de Nefrologie si Dializa Diaverum Targu MuresTârgu Mureş, RomaniaContact: 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