Recruiting
Phase 2
Phase 3

Clazakizumab

Sponsor:

CSL Behring

Code:

NCT05485961

Conditions

End Stage Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CSL300

Placebo

Study Details

Brief 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.

Conditions

End Stage Kidney Disease

Study ID

NCT05485961

Start date

Apr 27, 2024

Status verified date

Sep, 2026

Completion date

May 22, 2029

Anticipated

Primary completion date

May 22, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
  • Part 1 (Phase 2b) excludes subjects with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of subjects with a latent TB and at least 4 weeks of prophylactic TB treatment.
  • 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.

Study Design

Enrollment

3110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: CSL300 (low dose)(Phase 2b)

Intravenous (IV) administration

experimental: CSL300 (medium dose)(Phase 2b)

IV administration

experimental: CSL300 (high dose)(Phase 2b)

IV administration

placebo comparator: Placebo (Phase 2b)

IV administration

experimental: CSL300 (Phase 3)

IV administration

placebo comparator: Placebo (Phase 3)

IV administration

Interventions

CSL300

IV administration

Placebo

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

Primary outcome measure

  • Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b) [ Time Frame: Baseline and up to Week 12 ]
  • Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3) [ Time Frame: Approximately 5 years ]

Central Contacts and Locations

Central contacts

Trial Registration Coordinator

+1 610-878-4697clinicaltrials@cslbehring.com

Locations

Nephrology of North Alabama

Recruiting

Decatur, Alabama, United States, 35601

Nephrology Consultants, LLC

Recruiting

Huntsville, Alabama, United States, 35805

DaVita Clinical Research Montgomery

Recruiting

Montgomery, Alabama, United States, 36117

AKDHC Medical

Recruiting

Glendale, Arizona, United States, 85305

Kidney Disease Medical Group

Recruiting

Glendale, Arizona, United States, 91206

AKDHC Medical

Recruiting

Phoenix, Arizona, United States, 85018

AKDHC Medical

Recruiting

Tucson, Arizona, United States, 85705

Southern Arizona VA Health Care System

Recruiting

Tucson, Arizona, United States, 85723

National Institute of Clinical Research

Recruiting

Bakersfield, California, United States, 93309

California Institute of Renal Research

Recruiting

Chula Vista, California, United States, 91910

The Medical Research Group, Inc.

Recruiting

Fresno, California, United States, 93720

Davita Fullerton Dialysis Center

Recruiting

Fullerton, California, United States, 92832

National Institute of Clinical Research, Inc.

Recruiting

Fullerton, California, United States, 92835

National Institute of Clinical Research, Inc.

Recruiting

Garden Grove, California, United States, 92843

St. Jude Medical Center

Recruiting

Garden Grove, California, United States, 92843

National Institute of Clinical Research

Recruiting

Garden Grove, California, United States, 92844

Sherman Medical Group, Inc

Recruiting

Glendale, California, United States, 91204

Kidney Disease Medical Group

Recruiting

Glendale, California, United States, 91206

Renal Consultants Medical Group

Recruiting

Granada Hills, California, United States, 91344

Balboa Research

Recruiting

La Jolla, California, United States, 92037

California Institute of Renal Research

Recruiting

La Mesa, California, United States, 91942

Southern California Medical Research Center

Recruiting

La Palma, California, United States, 90623

Academic Medical Research Institute

Recruiting

Los Angeles, California, United States, 90022

National Institute of Clinical Research, Inc.

Recruiting

Los Angeles, California, United States, 90027

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Renal Medical Associates/NARI

Recruiting

Lynwood, California, United States, 90262

Amicis Research Center

Recruiting

Northridge, California, United States, 91324

FORMAT Medical Research

Recruiting

Oxnard, California, United States, 93036

National Institute of Clinical Research, Inc.

Recruiting

Pomona, California, United States, 91768

Van Buren Dialysis Center

Recruiting

Riverside, California, United States, 92504

National Nephrology Alliance Research - Riverside

Recruiting

Riverside, California, United States, 92505

Central Coast Nephrology Medical Corp

Recruiting

Salinas, California, United States, 93901

California Institute of Renal Research

Recruiting

San Diego, California, United States, 92111

North America Research Institute

Recruiting

San Dimas, California, United States, 91773

Nephrology Educational Services

Recruiting

Tarzana, California, United States, 91356

Valiance Clinical Research

Recruiting

Tarzana, California, United States, 91356

National Institute of Clinical Research, Inc

Recruiting

Victorville, California, United States, 92392

DaVita Vista Del Sol Dialysis

Recruiting

Victorville, California, United States, 92394

Western Nephrology

Recruiting

Arvada, Colorado, United States, 80002

Contacts

Trial Information Contact

303-232-3366kmydosh@westneph.com

Kidney Associates of Colorado, P.C.

Recruiting

Denver, Colorado, United States, 80210

Colorado Kidney Care

Recruiting

Denver, Colorado, United States, 80230

Greater Hartford Nephrology, LLC

Recruiting

Bloomfield, Connecticut, United States, 06002

Nephrology and Hypertension Associates PC

Recruiting

Middlebury, Connecticut, United States, 06762

- Boca Raton Regional - Research Physicians Network Alliance

Recruiting

Boca Raton, Florida, United States, 33431

Nova Clinical Research, LLC

Recruiting

Bradenton, Florida, United States, 34209

Contacts

South Florida Nephrology Group, PA

Recruiting

Coral Springs, Florida, United States, 33071

Family First Medical Research Center

Recruiting

Hialeah Gardens, Florida, United States, 33016

Advanced Medical Research Group

Recruiting

Hollywood, Florida, United States, 33021

Royal Research, Corp

Recruiting

Hollywood, Florida, United States, 33021

Elixia Pines

Recruiting

Hollywood, Florida, United States, 33024

South Florida Research Institute

Recruiting

Lauderdale Lakes, Florida, United States, 33313

South Florida Research Organization LLC

Recruiting

Medley, Florida, United States, 33166

Aviva Health Sciences

Recruiting

Miami, Florida, United States, 33125

Iconic Clinical Research Center

Recruiting

Miami, Florida, United States, 33126

Total Research Group, LLC

Recruiting

Miami, Florida, United States, 33126

Nephrology Associates of South Miami

Recruiting

Miami, Florida, United States, 33173

Floridian Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Infigo Clinical Research LLC

Recruiting

Sanford, Florida, United States, 32771

Florida Kidney Specialists

Recruiting

Temple Terrace, Florida, United States, 33637

Florida Premier Research Institute

Recruiting

Winter Park, Florida, United States, 32789

Coastal Medical Research, LLC

Recruiting

Brunswick, Georgia, United States, 31520

Renal Associates LLC

Recruiting

Columbus, Georgia, United States, 31904

National Clinical Trials

Recruiting

Cordele, Georgia, United States, 31015

American Clinical Trials

Recruiting

Douglasville, Georgia, United States, 30101

Georgia Nephrology

Recruiting

Lawrenceville, Georgia, United States, 30046

Contacts

Trial Information Contact

404-664-7631afelder@nephronet.com

NANI Research

Recruiting

Fort Wayne, Indiana, United States, 46804

Nephrology Physician's LLC

Recruiting

Mishawaka, Indiana, United States, 46545

Dunes Clinical Research LLC

Recruiting

Sioux City, Iowa, United States, 57049

Kansas Nephrology Physicians, PA

Recruiting

Wichita, Kansas, United States, 67214

Nephrology Associates of Kentuckiana, PSC

Recruiting

Louisville, Kentucky, United States, 40205

Renal Associates of Baton Rouge

Recruiting

Baton Rouge, Louisiana, United States, 70808

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Paragon Health, Inc

Recruiting

Kalamazoo, Michigan, United States, 49007

Michigan Kidney Consultants, PC

Recruiting

Pontiac, Michigan, United States, 48341

St. Clair Nephrology Research

Recruiting

Roseville, Michigan, United States, 48066

Center for Advanced Kidney Research, PLC

Recruiting

Saint Clair Shores, Michigan, United States, 48081

DCR Edina

Recruiting

Minneapolis, Minnesota, United States, 55404

Minneapolis VA Health Care System

Recruiting

Minneapolis, Minnesota, United States, 55439

Nephrology Associates, PC

Recruiting

Columbus, Mississippi, United States, 39705

- Nephrology and Hypertension Associates Ltd

Recruiting

Tupelo, Mississippi, United States, 38801

Clinical Research Consultants

Recruiting

Kansas City, Missouri, United States, 64111

Kansas City VA Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

DCI-Rockhill

Recruiting

Kansas City, Missouri, United States, 64131

GSR Enterprises, Inc.

Recruiting

Lincoln, Nebraska, United States, 68510

Great Plains Health - Nephrology

Recruiting

North Platte, Nebraska, United States, 69101

DaVita Clinical Research - Henderson

Recruiting

Henderson, Nevada, United States, 89074

Kidney Specialists of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89106

Sierra Nevada Specialty Care

Recruiting

Reno, Nevada, United States, 89511

Seacoast Kidney and Hypertension Specialists

Recruiting

Portsmouth, New Hampshire, United States, 03801

Hypertension & Nephrology Association

Recruiting

Eatontown, New Jersey, United States, 07724

New Jersey Kidney Care

Recruiting

Jersey City, New Jersey, United States, 07305

U.S. Renal Care - Gallup

Recruiting

Gallup, New Mexico, United States, 87301

Albany Medical College Committee of Research Involving Human Subjects

Recruiting

Albany, New York, United States, 12208

SUNY Downstate Medical Center Brooklyn

Recruiting

Brooklyn, New York, United States, 11203

Mattoo & Bhat Medical Associates, P.C.

Recruiting

College Point, New York, United States, 11356

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Albert Einstein College of Medicine - Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

James J Peters VA Medical Center

Recruiting

The Bronx, New York, United States, 10468

Metrolina Nephrology Associates, PA

Recruiting

Charlotte, North Carolina, United States, 28204

Durham Nephrology Associates, PA

Recruiting

Durham, North Carolina, United States, 27704

Duke Translational Medicine Institute

Recruiting

Durham, North Carolina, United States, 27705

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

North Carolina Nephrology, PA

Recruiting

Raleigh, North Carolina, United States, 27610

Nephrology Associates of the Carolinas

Recruiting

Shelby, North Carolina, United States, 28150

HNC Dialysis, Ltd.

Recruiting

Columbus, Ohio, United States, 43215

Northeast Clinical Research Center, LLC

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Clinical Renal Associates, LTD

Recruiting

Exton, Pennsylvania, United States, 19341

Lifespan Clinical Research

Recruiting

East Providence, Rhode Island, United States, 02915

Columbia Nephrology

Recruiting

Columbia, South Carolina, United States, 29203

CN Clinical Research LLC

Recruiting

Greenville, South Carolina, United States, 29605

Dialysis Clinic, Inc.

Recruiting

Spartanburg, South Carolina, United States, 29301

DaVita Clinical Research

Recruiting

Spartanburg, South Carolina, United States, 29306

Southeast Renal Research Institute

Recruiting

Chattanooga, Tennessee, United States, 37404

Contacts

Dialysis Clinic Inc - University Nephology

Recruiting

Knoxville, Tennessee, United States, 37920

Knoxville Kidney Center PLLC

Recruiting

Knoxville, Tennessee, United States, 37923

Lt. Col. Luke Weathers, Jr. VA Medical Center

Recruiting

Memphis, Tennessee, United States, 38105

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Cussimanio Research Group LLC

Recruiting

Austin, Texas, United States, 78751

Research Management, Inc.

Recruiting

Austin, Texas, United States, 78758

MW Clinical Research Center

Recruiting

Beaumont, Texas, United States, 77701

Dallas V.A. Medical Center

Recruiting

Dallas, Texas, United States, 75216

Dallas Nephrology Associates

Recruiting

Dallas, Texas, United States, 75234

US Renal Care

Recruiting

Dallas, Texas, United States, 75237

Davita Clinical Research

Recruiting

El Paso, Texas, United States, 79925

DaVita Clinical Research - Horizon

Recruiting

El Paso, Texas, United States, 79935

Fort Worth Renal Group

Recruiting

Fort Worth, Texas, United States, 76110

Clinical Research Strategies

Recruiting

Houston, Texas, United States, 77030

DaVita Clinical Research

Recruiting

Houston, Texas, United States, 77054

Aqua Research Institute

Recruiting

Houston, Texas, United States, 77058

Gulf Coast Clinical Research

Recruiting

Houston, Texas, United States, 77070

Houston Medical Research Institute, LLC

Recruiting

Houston, Texas, United States, 77074

Clinical Research Strategies, Inc.

Recruiting

Houston, Texas, United States, 77090

Southwest Houston Research

Recruiting

Houston, Texas, United States, 77099

Prime Clinical Research, Inc.

Recruiting

Mansfield, Texas, United States, 76063

Gamma Medical Research, Inc.

Recruiting

McAllen, Texas, United States, 78503

National Institute of Clinical Research, Inc.

Recruiting

San Antonio, Texas, United States, 78204

DaVita Clinical Research

Recruiting

San Antonio, Texas, United States, 78229

Davita Clinical Research

Recruiting

San Antonio, Texas, United States, 78251

DCR-San Antonio Stone Oak

Recruiting

San Antonio, Texas, United States, 78258

DaVita Clinical Research North Houston

Recruiting

Shenandoah, Texas, United States, 77384

Medrasa Clinical Research

Recruiting

Sherman, Texas, United States, 75092

Renal Research of Montgomery County

Recruiting

The Woodlands, Texas, United States, 77384

DCR-Norfolk Great Bridge

Recruiting

Chesapeake, Virginia, United States, 23320

Contacts

Nephrology Associates of Northern Virginia Inc

Recruiting

Fairfax, Virginia, United States, 22033

Contacts

Peninsula Kidney Associates

Recruiting

Hampton, Virginia, United States, 23666

Contacts

Trial Information Contact

757-637-7848ykireeva@pen-kid.com

Tidewater Kidney Specialists

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Richmond V.A. Medical Center

Recruiting

Richmond, Virginia, United States, 23249

Nephrology and Hypertension Associates

Recruiting

Bluefield, West Virginia, United States, 24701

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G2P4

Queen Elizabeth II Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A6

Contacts

St. Josephs Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

London Health Sciences Centre - University Hospital

Recruiting

London, Ontario, Canada, N6A 5A5

Lakeridge Health Oshawa

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Hôpital du Sacré-Cœur-de-Montréal

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Contacts

Maisonneuve-Rosemont Hospital

Recruiting

Montreal, Canada, H1T 2M4

Contacts

CHUM - Centre hospitalier de l'Universite de Montreal

Recruiting

Montreal, Canada, H2X 3E4

The Ottawa Hospital Research Institute

Recruiting

Ottawa, Canada, K1H 8L6

Ciussse-Chus

Recruiting

Sherbrooke, Canada, J1H 5N4

St. Michaels Hospital

Recruiting

Toronto, Canada, M5B 1W8

St Paul Hospital

Recruiting

Vancouver, Canada, V6Z 1Y6

Seven Oaks Hospital

Recruiting

Winnipeg, Canada, R2V 3M3

More Information

Sponsor

CSL Behring

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by CSL Behring on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.