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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

Combined Dose-finding and CV Outcomes Study with CSL300 (Clazakizumab) in Adult Subjects with ESKD Undergoing Dialysis (POSIBIL6ESKD)

Akama Hideto

CSL Behring K.K.

Aoyama Building, 1-2-3 Kita-Aoyama, Minato-ku, Tokyo

JPN-CHIKEN@csl.com.au

Akama Hideto

CSL Behring K.K.

Aoyama Building, 1-2-3 Kita-Aoyama, Minato-ku, Tokyo

+81-3-4213-0191

JPN-CHIKEN@csl.com.au

Recruiting

Sept. 20, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

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)

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

Both

ASCVD in patients with ESKD

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

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

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 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)

July. 12, 2024

Yes

Plan Description: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Supporting information: Protocol and Statistical Analysis Plan (SAP) will also be provided. Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available. Access Criteria: Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that have been appropriately anonymized will be available.

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