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NCT05485961

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

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-21

Study Completion Date

2029-08-30

Brief Summary

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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 cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.

Detailed Description

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Conditions

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Atherosclerotic Cardiovascular Disease End Stage Kidney Disease Atherosclerotic Cardiovascular Disease in Patients With ESKD

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.

Interventions

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CSL300

IV administration

Intervention Type DRUG

Placebo

Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.

Intervention Type DRUG

Other Intervention Names

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Clazakizumab

Eligibility Criteria

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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
* -Clinically significant active infection or history of opportunistic or invasive fungal infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

CSL Behring LLC

Other Identifiers

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2022-500273-14-00

Identifier Type: OTHER

Identifier Source: secondary_id

CSL300_2301

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

CSL300 (low dose)(Phase 2b)

CSL300

CSL300 (medium dose)(Phase 2b)

CSL300

CSL300 (high dose)(Phase 2b)

CSL300

Placebo (Phase 2b)

Placebo

CSL300 (Phase 3)

CSL300

Placebo (Phase 3)

Placebo

Interventions

CSL300

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

CSL Behring

Responsible Party

Principal Investigators

Study Director

Locations

Nephrology of North Alabama

84000149 - Nephrology Consultants, LLC

84000340 - DaVita Clinical Research Montgomery

84000552 - AKDHC Medical

84000178 - Kidney Disease Medical Group

84000231 - AKDHC Medical

84000286 - AKDHC Medical

84000622 - Southern Arizona VA Health Care System

84000145 - National Institute of Clinical Research

84000151 - National Institute of Clinical Research

84000277 - Amicis Research Center

84000241 - California Institute of Renal Research

The Medical Research Group, Inc.

84000462 - Davita Fullerton Dialysis Center

84000574 - National Institute of Clinical Research, Inc.

84000464 - St. Jude Medical Center

84000573 - National Institute of Clinical Research, Inc.

84000152 - National Institute of Clinical Research

84000531 - Sherman Medical Group, Inc

84000230 - Kidney Disease Medical Group

84000379 - Renal Consultants Medical Group

84000631 - Balboa Research

84000221 - California Institute of Renal Research

84000235 - California Institute of Renal Research

84000198 - Southern California Medical Research Center

84000467 - Southern California Medical Research Center

84000329 - Academic Medical Research Institute

84000439 - National Institute of Clinical Research, Inc.

84000158 - DaVita Carabello Dialysis Center

84000175 - Renal Medical Associates/NARI

84000279 - Amicis Research Center

84000533 - FORMAT Medical Research

84000331 - Van Buren Dialysis Center

84000228 - National Nephrology Alliance Research - Riverside

84000492 - Central Coast Nephrology Medical Corp

84000238 - California Institute of Renal Research

84000143 - California Institute of Renal Research

84000330 - North America Research Institute

84000341 - North America Research Institute

84000281 - Satellite Healthcare

84000440 - Nephrology Educational Services

84000536 - Valiance Clinical Research

84000278 - Amicis Research Center

84000323 - National Institute of Clinical Research, Inc

84000174 - DaVita Vista Del Sol Dialysis

84000589 - Western Nephrology