RECRUITING

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

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Conditions

Atherosclerotic Cardiovascular DiseaseEnd Stage Kidney DiseaseAtherosclerotic Cardiovascular Disease in Patients With ESKDEnd Stage Kidney Disease (ESKD)Myocardial infarction (MI)Atherosclerotic cardiovascular disease (ASCVD)Coronary artery diseasePeripheral artery diseaseDiabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-10-21
Study Completion:2029-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05485961

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female at least 18 years of age
  2. * A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks
  3. * Serum hs-CRP ≥ 2.0 mg/L
  4. * A diagnosis of diabetes mellitus OR ASCVD
  1. * Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3)
  2. * Concomitant use of systemic immunosuppressant drugs
  3. * Abnormal LFTs
  4. * Any life-threatening disease expected to result in death within 12 months
  5. * A history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease
  6. * Clinically significant active infection or history of opportunistic or invasive fungal infection

Contacts and Locations

Study Contact

Trial Registration Coordinator
CONTACT
+1 610-878-4697
clinicaltrials@cslbehring.com

Principal Investigator

Study Director
STUDY_DIRECTOR
CSL Behring LLC

Study Locations (Sites)

84000149 - Nephrology Consultants, LLC
Huntsville, Alabama, 35805
United States
84000340 - DaVita Clinical Research Montgomery
Montgomery, Alabama, 36117
United States
84000552 - AKDHC Medical
Glendale, Arizona, 85305
United States
84000178 - Kidney Disease Medical Group
Glendale, Arizona, 91206
United States
84000231 - AKDHC Medical
Phoenix, Arizona, 85018
United States
84000286 - AKDHC Medical
Tucson, Arizona, 85705
United States
84000145 - National Institute of Clinical Research
Bakersfield, California, 93309
United States
84000151 - National Institute of Clinical Research
Bakersfield, California, 93309
United States
84000277 - Amicis Research Center
Beverly Hills, California, 90211
United States
84000241 - California Institute of Renal Research
Chula Vista, California, 91910
United States
84000462 - Davita Fullerton Dialysis Center
Fullerton, California, 92832
United States
84000574 - National Institute of Clinical Research, Inc.
Fullerton, California, 92835
United States
84000464 - St. Jude Medical Center
Garden Grove, California, 92843
United States
84000573 - National Institute of Clinical Research, Inc.
Garden Grove, California, 92843
United States
84000152 - National Institute of Clinical Research
Garden Grove, California, 92844
United States
84000531 - Sherman Medical Group, Inc
Glendale, California, 91204
United States
84000230 - Kidney Disease Medical Group
Glendale, California, 91206
United States
84000379 - Renal Consultants Medical Group
Granada Hills, California, 91344
United States
84000221 - California Institute of Renal Research
La Mesa, California, 91942
United States
84000235 - California Institute of Renal Research
La Mesa, California, 91942
United States
84000198 - Southern California Medical Research Center
La Palma, California, 90623
United States
84000467 - Southern California Medical Research Center
La Palma, California, 90623
United States
84000329 - Academic Medical Research Institute
Los Angeles, California, 90022
United States
84000439 - National Institute of Clinical Research, Inc.
Los Angeles, California, 90027
United States
84000158 - DaVita Carabello Dialysis Center
Los Angeles, California, 90033
United States
84000175 - Renal Medical Associates/NARI
Lynwood, California, 90262
United States
84000279 - Amicis Research Center
Northridge, California, 91324
United States
84000533 - FORMAT Medical Research
Oxnard, California, 93036
United States
84000331 - Van Buren Dialysis Center
Riverside, California, 92504
United States
84000228 - National Nephrology Alliance Research - Riverside
Riverside, California, 92505
United States
84000238 - California Institute of Renal Research
San Diego, California, 92111
United States
84000143 - California Institute of Renal Research
San Diego, California, 92123
United States
84000330 - North America Research Institute
San Dimas, California, 91773
United States
84000341 - North America Research Institute
San Dimas, California, 91773
United States
84000281 - Satellite Healthcare
San Jose, California, 95126
United States
84000440 - Nephrology Educational Services
Tarzana, California, 91356
United States
84000278 - Amicis Research Center
Vacaville, California, 95687
United States
84000323 - National Institute of Clinical Research, Inc
Victorville, California, 92392
United States
84000174 - DaVita Vista Del Sol Dialysis
Victorville, California, 92394
United States
84000454 - Kidney Associates of Colorado, P.C.
Denver, Colorado, 80210
United States
84000223 - Colorado Kidney Care
Denver, Colorado, 80230
United States
84000176 - Greater Hartford Nephrology, LLC
Bloomfield, Connecticut, 06002
United States
84000173 - Nephrology and Hypertension Associates PC
Middlebury, Connecticut, 06762
United States
84000494 - Nephrology Associates (Delaware)
Newark, Delaware, 19713
United States
84000441 - Boca Raton Regional - Research Physicians Network Alliance
Boca Raton, Florida, 33431
United States
84000193 - Horizon Research Group LLC
Coral Gables, Florida, 33134
United States
84000443 - South Florida Nephrology Group, PA
Coral Springs, Florida, 33071
United States
84000406 - Elixia Pines
Hollywood, Florida, 33024
United States
84000140 -South Florida Research Institute
Lauderdale Lakes, Florida, 33313
United States
84000527 - Floridian Clinical Research
Miami Lakes, Florida, 33016
United States
84000495 - Total Research Group, LLC
Miami, Florida, 33126
United States
84000362 - Kidney and Hypertension Specialists of Miami
Miami, Florida, 33150
United States
84000182 - Nephrology Associates of South Miami
Miami, Florida, 33173
United States
84000400 - Elixia Central Florida
Orlando, Florida, 32806
United States
84000139 - Genesis Clinical Research
Tampa, Florida, 33603
United States
84000532 - Florida Kidney Specialists
Temple Terrace, Florida, 33637
United States
84000426 - Florida Premier Research Institute
Winter Park, Florida, 32789
United States
84000326 - Coastal Medical Research, LLC
Brunswick, Georgia, 31520
United States
84000157 - Renal Associates LLC
Columbus, Georgia, 31904
United States
84000327 - American Clinical Trials
Douglasville, Georgia, 30101
United States
84000194 - Atekha Nephrology Clinic LLC
Statesboro, Georgia, 30458
United States
84000453 - Nephrology Physician's LLC
Mishawaka, Indiana, 46545
United States
84000534 - Dunes Clinical Research LLC
Sioux City, Iowa, 57049
United States
84000374 - Kansas Nephrology Physicians, PA
Wichita, Kansas, 67214
United States
84000554 - Nephrology Associates of Kentuckiana, PSC
Louisville, Kentucky, 40205
United States
84000550 - Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808
United States
84000465 - Paragon Health, Inc
Kalamazoo, Michigan, 49007
United States
84000408 - Michigan Kidney Consultants, PC
Pontiac, Michigan, 48341
United States
84000171 - St. Clair Nephrology Research
Roseville, Michigan, 48066
United States
84000237 - Center for Advanced Kidney Research, PLC
Saint Clair Shores, Michigan, 48081
United States
84000146 - DCR Edina
Minneapolis, Minnesota, 55404
United States
84000338 - DCR Edina
Minneapolis, Minnesota, 55404
United States
84000225 - Southwest Mississippi Nephrology PLLC
Brookhaven, Mississippi, 39601
United States
84000153 - Nephrology Associates, PC
Columbus, Mississippi, 39705
United States
84000144 - Nephrology and Hypertension Associates Ltd
Tupelo, Mississippi, 38801
United States
84000147 - Clinical Research Consultants
Kansas City, Missouri, 64111
United States
84000328 - GSR Enterprises, Inc.
Lincoln, Nebraska, 68510
United States
84000222 - Great Plains Health - Nephrology
North Platte, Nebraska, 69101
United States
84000420 - DaVita Clinical Research - Henderson
Henderson, Nevada, 89074
United States
84000337 - Kidney Specialists of Southern Nevada
Las Vegas, Nevada, 89106
United States
84000148 - Sierra Nevada Specialty Care
Reno, Nevada, 89511
United States
84000141 - Seacoast Kidney and Hypertension Specialists
Portsmouth, New Hampshire, 03801
United States
84000436 - Hypertension & Nephrology Association
Eatontown, New Jersey, 07724
United States
84000452 - New Jersey Kidney Care
Jersey City, New Jersey, 07305
United States
84000155 - DaVita Clinic Research Bronx
Bronx, New York, 10461
United States
84000276 - Albert Einstein College of Medicine - Montefiore Medical Center
Bronx, New York, 10467
United States
84000184 - Mattoo & Bhat Medical Associates, P.C.
College Point, New York, 11356
United States
84000191 - Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28204
United States
84000150 - Durham Nephrology Associates, PA
Durham, North Carolina, 27704
United States
84000232 - East Carolina University
Greenville, North Carolina, 27858
United States
84000410 - North Carolina Nephrology, PA
Raleigh, North Carolina, 27610
United States
84000548 - HNC Dialysis, Ltd.
Columbus, Ohio, 43215
United States
84000234 - Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017
United States
84000192 - Columbia Nephrology
Columbia, South Carolina, 29203
United States
84000229 - DaVita Clinical Research
Spartanburg, South Carolina, 29306
United States
84000180 - Knoxville Kidney Center PLLC
Knoxville, Tennessee, 37923
United States
84000451 - Cussimanio Research Group LLC
Austin, Texas, 78751
United States
84000438 - Research Management, Inc.
Austin, Texas, 78758
United States
84000457 - US Renal Care
Dallas, Texas, 75237
United States
84000354 - Davita Clinical Research
El Paso, Texas, 79925
United States
84000421 - DaVita Clinical Research - Horizon
El Paso, Texas, 79935
United States
84000458 - Fort Worth Renal Group
Fort Worth, Texas, 76110
United States
84000350 - DaVita Clinical Research
Houston, Texas, 77054
United States
84000498 - DaVita Clinical Research
Houston, Texas, 77054
United States
84000450 - Houston Medical Research Institute, LLC
Houston, Texas, 77074
United States
84000360 - Clinical Research Strategies, Inc.
Houston, Texas, 77090
United States
84000196 - Southwest Houston Research
Houston, Texas, 77099
United States
84000373 - Gamma Medical Research, Inc.
McAllen, Texas, 78503
United States
84000324 - National Institute of Clinical Research, Inc.
San Antonio, Texas, 78204
United States
84000351 - DaVita Clinical Research
San Antonio, Texas, 78229
United States
84000419 - Davita Clinical Research
San Antonio, Texas, 78251
United States
84000553 - DCR-San Antonio Stone Oak
San Antonio, Texas, 78258
United States
84000339 - DaVita Clinical Research North Houston
Shenandoah, Texas, 77384
United States
84000535 - DCR-Norfolk Great Bridge
Chesapeake, Virginia, 23320
United States
84000424 - Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia, 22033
United States
84000138 - Peninsula Kidney Associates
Hampton, Virginia, 23666
United States
84000156 - Tidewater Kidney Specialists
Norfolk, Virginia, 23502
United States
84000336 - Nephrology and Hypertension Associates
Bluefield, West Virginia, 24701
United States

Collaborators and Investigators

Sponsor: CSL Behring

  • Study Director, STUDY_DIRECTOR, CSL Behring LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-21
Study Completion Date2029-08-30

Study Record Updates

Study Start Date2022-10-21
Study Completion Date2029-08-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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