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

JRCT ID: jRCT2061240044

Registered date:06/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: ASCVD in patients with ESKD
• Date of first enrollment: 01/11/2024
• Target sample size: 2190
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Mexico,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Singapore,Japan,Slovakia,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,UK,Japan,USA,Japan
• Study type: Interventional
• Intervention(s): CSL300 (clazakizumab) 5 mg or placebo, intraveneously administered every 4 weeks.

Outcome(s)

Primary Outcome

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 Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Akama Hideto
• Secondary ID(s): NCT05485961,2022-500273-14-00