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Clinical Trials List

Protocol NumberCSL300_2301
Not yet recruiting

2024-10-03 - 2029-10-04

Phase II/III

Recruiting7

ICD-10I25.10

Atherosclerotic heart disease of native coronary artery without angina pectoris

ICD-9429.2

Cardiovascular disease, unspecified

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

  • Sponsor

    CSL Behring LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator CHENG-HSU CHEN Division of Nephrology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 彭渝森 Division of Nephrology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 許恆榮 Division of Nephrology
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Chin Lee Division of Nephrology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Mai-Szu Wu Division of Nephrology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi wen chiu Division of Nephrology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Chin Kao
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Kidney Disease

Objectives

Primary Objective: • To evaluate the efficacy on high-sensitivity C-reactive protein (hs-CRP) reduction of different intravenous doses of CSL300 administered every 4 weeks.

Test Drug

injection

Active Ingredient

CSL300
CSL300_Placebo

Dosage Form

270
270

Dosage

1.25 mg/ml
2ml/vial

Endpoints

Primary Endpoint:
• The change from Baseline on the log scale in hs-CRP to Week 12.

Inclution Criteria

To be enrolled into the study, subjects must meet ALL of the following inclusion criteria:
1. Capable of providing written informed consent by subject (or legally acceptable
representative) and willing and able to adhere to all protocol requirements.
2. Male or female at least 18 years of age at the time of providing written informed
consent.
3. A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks before
Screening.
4. Serum hs-CRP ≥ 2.0 mg/L measured during Screening.
5. A diagnosis of any of the following:
a. diabetes mellitus
OR
b. ASCVD as evidenced by at least 1 of the following:
• A history of CAD, defined as at least 1 of the following:
o a history of angiography (coronary angiogram or computed
tomography angiography) documenting ≥ 50% stenosis in at least
1 major epicardial vessel defined as left main coronary artery, left
anterior descending artery, left circumflex artery, right coronary artery,
or major branches (eg, diagonal artery, obtuse marginal or posterior
descending artery).
o a history of MI.
o a history of percutaneous coronary intervention (PCI) or coronary
artery bypass graft (CABG).
• a history of PAD, defined as at least 1 of the following:
o previous revascularization procedure (eg, aortofemoral bypass surgery,
axillofemoral bypass surgery, limb bypass surgery, or percutaneous
transluminal angioplasty).
o previous limb or foot amputation for arterial vascular disease, or
 significant peripheral artery stenosis (≥ 50%) documented by
angiography or by duplex ultrasound.
 a history of intermittent claudication (or equivalent ischemic
symptoms) AND ankle / arm blood pressure (BP) ratio ≤ 0.9.
o previous carotid revascularization or asymptomatic carotid artery
stenosis ≥ 50% diagnosed by duplex ultrasound or angiography.

Exclusion Criteria

Subjects must NOT be enrolled into the study if they meet any of the following exclusion
criteria:
1. Subjects who were randomized in Part 1 (phase 2b) are not eligible to participate in
Part 2 (phase 3).
Exclusions Related to the Risk of Infection
2. Concomitant use of systemic immunosuppressant agents (refer to Section 6.9.1 and
Section 6.9.2 [Part 1 {phase 2b}] and Section 14.9.1 and Section 14.9.2 [Part 2
{phase 3}]).
3. Primary immunodeficiency.
4. Positive test for tuberculosis (TB) using an interferon-γ release assay (eg,
QuantiFERON-TB Gold) during Screening.
5. History of latent TB without completion of full course of prophylactic treatment.
6. Evidence of HIV infection during Screening.
7. Seropositivity for hepatitis B surface antigen (HBsAg), or positive hepatitis B virus
(HBV) DNA during Screening (refer to Section 18.4.2 and Table 16).
8. Seropositivity for hepatitis C virus (HCV) ribonucleic acid (RNA) during Screening.
9. Diagnosis of clinically significant active infection, defined as current (within 14 days
of start of Screening) clinical diagnosis of infection requiring ongoing systemic
antimicrobial therapy or any infection that, in the opinion of the investigator, would
cause unacceptable risks to the subject if anti-IL-6 therapy is started.
10. History of OR current invasive fungal infection OR other opportunistic infection OR
recurrent cellulitis (defined as 2 or more episodes in the year prior to screening).
11. Administration of a live vaccine within 6 weeks of start of Screening.
12. Presence of urinary catheter.
13. Evidence of wet gangrene or nonhealing ulcers.

The Estimated Number of Participants

  • Taiwan

    42 participants

  • Global

    2190 participants

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