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

CSL Behring logo

CSL Behring

Status and phase

Invitation-only
Phase 3
Phase 2

Conditions

Atherosclerotic Cardiovascular Disease
End Stage Kidney Disease

Treatments

Drug: CSL300
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05485961
2022-500273-14-00 (Other Identifier)
CSL300_2301

Details and patient eligibility

About

This is a 2-part (phase 2b/3) 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 on CV outcomes and safety in subjects with ASCVD or diabetes mellitus and evidence of systemic inflammation who are undergoing maintenance dialysis.

Enrollment

2,310 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3)
  • Concomitant use of systemic immunosuppressant drugs
  • Abnormal LFTs
  • 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

2,310 participants in 6 patient groups, including a placebo group

CSL300 (low dose)(Phase 2b)
Experimental group
Description:
Intravenous (IV) administration
Treatment:
Drug: CSL300
CSL300 (medium dose)(Phase 2b)
Experimental group
Description:
IV administration
Treatment:
Drug: CSL300
CSL300 (high dose)(Phase 2b)
Experimental group
Description:
IV administration
Treatment:
Drug: CSL300
Placebo (Phase 2b)
Placebo Comparator group
Description:
IV administration
Treatment:
Drug: Placebo
Drug: Placebo
CSL300 (Phase 3)
Experimental group
Description:
IV administration
Treatment:
Drug: CSL300
Placebo (Phase 3)
Placebo Comparator group
Description:
IV administration
Treatment:
Drug: Placebo
Drug: Placebo

Trial contacts and locations

71

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Central trial contact

Trial Registration Coordinator

Data sourced from clinicaltrials.gov

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