Combined Dose-finding and CV Outcomes Study with CSL300 (Clazakizumab) in Adult Subjects with ESKD Undergoing Dialysis

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061240044

Enrollment

2190

Registered

2024-08-06

Start date

2024-10-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ASCVD in patients with ESKD End Stage Kidney Disease (ESKD), Myocardial infarction (MI), Atherosclerotic cardiovascular disease (ASCVD), Coronary artery disease, Peripheral artery disease, Diabetes

Interventions

CSL300 (clazakizumab) 5 mg or placebo, intraveneously administered every 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female at least 18 years of age 2. A diagnosis of end stage kidney disease (ESKD) undergoing maintenance dialysis for at least 12 weeks 3. Serum hs-CRP >= 2.0 mg/L 4. A diagnosis of diabetes mellitus OR atherosclerotic cardiovascular disease (ASCVD)

Exclusion criteria

Exclusion criteria: 1. Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3) 2. Concomitant use of systemic immunosuppressant drugs 3. Abnormal liver function tests 4. Any life-threatening disease expected to result in death within 12 months 5. A history of gastrointestinal perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease 6. Clinically significant active infection or history of opportunistic or invasive fungal infection

Design outcomes

Primary

Measure	Time frame
Primary outcome for Part 2 (Phase 3) cardiovascular (CV) outcome study only: Time to first occurrence of CV death or myocardial infaction (MI). (will be followed for approximately 5 years)	—

Secondary

Measure	Time frame
Secondary outcomes for Part 2 (Phase 3) CV outcome study only: Time to first occurrence of all-cause death or MI. Time to first occurrence of CV death, MI, or ischemic stroke. Time to first occurrence of CV death. Time to first occurrence of all-cause death. Time to first occurrence of CV death, MI, or major adverse limb event. Time to first occurrence of CV death, MI, or hospitalization for heart failure. Total number of CV hospitalizations. Total number of heart failure hospitalizations and urgent visits. Total number of hospitalizations. (will be followed for approximately 5 years)	—

Measure

Time frame

Secondary outcomes for Part 2 (Phase 3) CV outcome study only: Time to first occurrence of all-cause death or MI. Time to first occurrence of CV death, MI, or ischemic stroke. Time to first occurrence of CV death. Time to first occurrence of all-cause death. Time to first occurrence of CV death, MI, or major adverse limb event. Time to first occurrence of CV death, MI, or hospitalization for heart failure. Total number of CV hospitalizations. Total number of heart failure hospitalizations and urgent visits. Total number of hospitalizations. (will be followed for approximately 5 years)

—

Countries

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Mexico, Norway, Poland, Portugal, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, UK, USA

Contacts

Public ContactHideto Akama

CSL Behring K.K.

JPN-CHIKEN@csl.com.au+81-3-4213-0191

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026