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
- Hashima-gun, Higashiosaka-shi, Hiroshima, Hokkaido, Ibaraki, Ichinomiya-shi, Inashiki-gun, Kagoshima, Kamakura-shi, Kanazawa, Kitakyushu-shi, Kurume, Kurume-shi, Kusatsu-shi, Kyoto, Maebashi, Matsubara-shi, Nagaoka-Shi, Nagoya, Ogaki-Shi, Ōmihachiman, Oyama-shi, Sakaimachi, Sapporo, Shinjuku-Ku, Takasaki-Shi, Tsukuba, Ube-shi, Urayasu-shi, Yamagata, Yokohama, and Yonago-shi, JapanSee the 36 sites
- Phase
- Phase 2/3
Where in Japan
- Matsunami General HospitalHashima-gun, JapanTaking people
- Ishikiriseiki HospitalHigashiosaka-shi, JapanTaking people
- NHO Hiroshimanishi Medical CenterHiroshima, JapanTaking people
- Miki Internal Medicine Urology ClinicHokkaido, JapanTaking people
- University of Tsukuba - Mito Kyodo General HospitalIbaraki, JapanTaking people
- Daiyukai Daiichi HospitalIchinomiya-shi, JapanTaking people
- Tokyo Medical University Ibaraki Medical CenterInashiki-gun, JapanTaking people
- Ueyama HospitalKagoshima, JapanTaking people
- Ueyama Jin ClinicKagoshima, JapanNo longer taking part
- Shonan Kamakura General HospitalKamakura-shi, JapanTaking people
- National Hospital Organization Kanazawa Medical CenterKanazawa, JapanTaking people
- Kokura Memorial HospitalKitakyushu-shi, JapanTaking people
- Steel Memorial Yawata HospitalKitakyushu-shi, JapanTaking people
- Kurume University HospitalKurume, JapanNo longer taking part
- St. Mary's HospitalKurume-shi, JapanTaking people
- Omi freai HospitalKusatsu-shi, JapanTaking people
- Rakuwakai Otowa Kinen HospitalKyoto, JapanTaking people
- Joumou Ohashi ClinicMaebashi, JapanTaking people
- Maebashi Hirosegawa ClinicMaebashi, JapanTaking people
- Matsubara Tokushukai HospitalMatsubara-shi, JapanTaking people
- Nagaoka Red-Cross HospitalNagaoka-Shi, JapanTaking people
- Chubu Rosai HospitalNagoya, JapanTaking people
- Daido HospitalNagoya, JapanTaking people
- Ogaki Tokushukai HospitalOgaki-Shi, JapanTaking people
- Omihachiman Community Medical Center - Kidney CenterŌmihachiman, JapanTaking people
- Oguranaika Jin CinicOyama-shi, JapanTaking people
- Ibaraki Seinan Medical Center HospitalSakaimachi, JapanTaking people
- Teine Urological ClinicSapporo, JapanTaking people
- Tokyo Womens Med UniversityShinjuku-Ku, JapanTaking people
- Kurosawa HospitalTakasaki-Shi, JapanTaking people
- Kikuchi Medical ClinicTsukuba, JapanTaking people
- St.Hill HospitalUbe-shi, JapanTaking people
- Juntendo University Urayasu HospitalUrayasu-shi, JapanTaking people
- Yamagata Tokushukai HospitalYamagata, JapanTaking people
- Bosei Kannai ClinicYokohama, JapanTaking people
- Sanin Rosai HospitalYonago-shi, JapanTaking 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.