Under construction – not a live service
Sign in
Taking people in GermanyPhase 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
Berlin, Hessen, Kaiserslautern, Kiel, Leipzig, Mainz, and Villingen-Schwenningen, GermanySee the 7 sites
Phase
Phase 2/3

AI summary: who the study is looking for

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.

Read by machine on 12 November 2026.

Where in Germany

  • Charité Universitätsmedizin BerlinBerlin, GermanyContact: Trial Registration CoordinatorTaking people
  • Nierenzentrum Bad KönigHessen, GermanyContact: Trial Registration CoordinatorTaking people
  • Westpfalz-Klinikum GmbHKaiserslautern, GermanyContact: Trial Registration CoordinatorTaking people
  • UKSH - Universitatsklinik Schleswig-HolsteinKiel, GermanyContact: Trial Registration CoordinatorNo longer taking part
  • Kuratorium fuer Dialyse und Nierentransplantation e.V. - KfH-Nierenzentrum - St. GeorgLeipzig, GermanyContact: Trial Registration CoordinatorTaking people
  • Universitätsmedizin der Johannes Gutenberg-Universität MainzMainz, GermanyContact: Trial Registration CoordinatorNo longer taking part
  • Nephrologisches Zentrum Villingen-SchwenningenVillingen-Schwenningen, GermanyContact: Trial Registration CoordinatorTaking 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?

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

Print a page for my doctor

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