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Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
Sponsor: CSL Behring
Summary
This is a two-part, phase 2b and phase 3 combined 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 vs placebo 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3110
Start Date
2024-04-27
Completion Date
2029-05-22
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
CSL300
IV administration
Placebo
Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.
Locations (566)
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
Balboa Research
La Jolla, California, United States
California Institute of Renal Research
La Mesa, California, United States
Southern California Medical Research Center
La Palma, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
National Institute of Clinical Research, Inc.
Los Angeles, California, United States
DaVita Carabello Dialysis Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Renal Medical Associates/NARI
Lynwood, California, United States
Amicis Research Center
Northridge, California, United States
FORMAT Medical Research
Oxnard, California, United States
National Institute of Clinical Research, Inc.
Pomona, California, United States
Van Buren Dialysis Center
Riverside, California, United States
National Nephrology Alliance Research - Riverside
Riverside, California, United States
Central Coast Nephrology Medical Corp
Salinas, California, United States
California Institute of Renal Research
San Diego, California, United States
California Institute of Renal Research
San Diego, California, United States
North America Research Institute
San Dimas, California, United States
Satellite Healthcare
San Jose, California, United States
Nephrology Educational Services
Tarzana, California, United States
Valiance Clinical Research
Tarzana, California, United States
Amicis Research Center
Vacaville, California, United States
National Institute of Clinical Research, Inc
Victorville, California, United States
DaVita Vista Del Sol Dialysis
Victorville, California, United States
Western Nephrology
Arvada, Colorado, United States
Kidney Associates of Colorado, P.C.
Denver, Colorado, United States
Colorado Kidney Care
Denver, Colorado, United States
Greater Hartford Nephrology, LLC
Bloomfield, Connecticut, United States
Nephrology and Hypertension Associates PC
Middlebury, Connecticut, United States
Nephrology Associates (Delaware)
Newark, Delaware, United States
- Boca Raton Regional - Research Physicians Network Alliance
Boca Raton, Florida, United States
Nova Clinical Research, LLC
Bradenton, Florida, United States
Access Research Institute
Brooksville, Florida, United States
Horizon Research Group LLC
Coral Gables, Florida, United States
South Florida Nephrology Group, PA
Coral Springs, Florida, United States
Family First Medical Research Center
Hialeah Gardens, Florida, United States
Advanced Medical Research Group
Hollywood, Florida, United States
Royal Research, Corp
Hollywood, Florida, United States
Elixia Pines
Hollywood, Florida, United States
South Florida Research Institute
Lauderdale Lakes, Florida, United States
South Florida Research Organization LLC
Medley, Florida, United States
Aviva Health Sciences
Miami, Florida, United States
Iconic Clinical Research Center
Miami, Florida, United States
Total Research Group, LLC
Miami, Florida, United States
Kidney and Hypertension Specialists of Miami
Miami, Florida, United States
Nephrology Associates of South Miami
Miami, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
Elixia Central Florida
Orlando, Florida, United States
Infigo Clinical Research LLC
Sanford, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
Florida Kidney Specialists
Temple Terrace, Florida, United States
Florida Premier Research Institute
Winter Park, Florida, United States
Southwest Georgia Nephrology Clinic
Albany, Georgia, United States
Coastal Medical Research, LLC
Brunswick, Georgia, United States
Renal Associates LLC
Columbus, Georgia, United States
National Clinical Trials
Cordele, Georgia, United States
American Clinical Trials
Douglasville, Georgia, United States
Georgia Nephrology
Lawrenceville, Georgia, United States
Atekha Nephrology Clinic LLC
Statesboro, Georgia, United States
NANI Research
Fort Wayne, Indiana, United States
Nephrology Physician's LLC
Mishawaka, Indiana, United States
Dunes Clinical Research LLC
Sioux City, Iowa, United States
Kansas Nephrology Physicians, PA
Wichita, Kansas, United States
Nephrology Associates of Kentuckiana, PSC
Louisville, Kentucky, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Paragon Health, Inc
Kalamazoo, Michigan, United States
Michigan Kidney Consultants, PC
Pontiac, Michigan, United States
St. Clair Nephrology Research
Roseville, Michigan, United States
Center for Advanced Kidney Research, PLC
Saint Clair Shores, Michigan, United States
DCR Edina
Minneapolis, Minnesota, United States
DCR Edina
Minneapolis, Minnesota, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States
Southwest Mississippi Nephrology PLLC
Brookhaven, Mississippi, United States
Nephrology Associates, PC
Columbus, Mississippi, United States
- Nephrology and Hypertension Associates Ltd
Tupelo, Mississippi, United States
Clinical Research Consultants
Kansas City, Missouri, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
DCI-Rockhill
Kansas City, Missouri, United States
GSR Enterprises, Inc.
Lincoln, Nebraska, United States