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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - \- 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 Who Should NOT Join This Trial: - \- 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

CSL300

IV administration

DRUG

Placebo

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

Locations (20)

Nephrology of North Alabama
Decatur, Alabama, United States
Nephrology Consultants, LLC
Huntsville, Alabama, United States
DaVita Clinical Research Montgomery
Montgomery, Alabama, United States
AKDHC Medical
Glendale, Arizona, United States
Kidney Disease Medical Group
Glendale, Arizona, United States
AKDHC Medical
Phoenix, Arizona, United States
AKDHC Medical
Tucson, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
National Institute of Clinical Research
Bakersfield, California, United States
Amicis Research Center
Beverly Hills, California, United States
California Institute of Renal Research
Chula Vista, California, United States
The Medical Research Group, Inc.
Fresno, California, United States
Davita Fullerton Dialysis Center
Fullerton, California, United States
National Institute of Clinical Research, Inc.
Fullerton, California, United States
National Institute of Clinical Research, Inc.
Garden Grove, California, United States
St. Jude Medical Center
Garden Grove, California, United States
National Institute of Clinical Research
Garden Grove, California, United States
Sherman Medical Group, Inc
Glendale, California, United States
Kidney Disease Medical Group
Glendale, California, United States
Renal Consultants Medical Group
Granada Hills, California, United States