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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

Condition
Atherosclerotic Cardiovascular Disease
Intervention / Treatment

-

Contacts and Locations

Huntsville

84000149 - Nephrology Consultants, LLC, Huntsville, Alabama, United States, 35805

Montgomery

84000340 - DaVita Clinical Research Montgomery, Montgomery, Alabama, United States, 36117

Glendale

84000552 - AKDHC Medical, Glendale, Arizona, United States, 85305

Glendale

84000178 - Kidney Disease Medical Group, Glendale, Arizona, United States, 91206

Phoenix

84000231 - AKDHC Medical, Phoenix, Arizona, United States, 85018

Tucson

84000286 - AKDHC Medical, Tucson, Arizona, United States, 85705

Bakersfield

84000145 - National Institute of Clinical Research, Bakersfield, California, United States, 93309

Bakersfield

84000151 - National Institute of Clinical Research, Bakersfield, California, United States, 93309

Beverly Hills

84000277 - Amicis Research Center, Beverly Hills, California, United States, 90211

Chula Vista

84000241 - California Institute of Renal Research, Chula Vista, California, United States, 91910

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CSL Behring,

Study Director, STUDY_DIRECTOR, CSL Behring LLC

Study Record Dates

2029-08-30