Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
CSL Behring
Study ID
NCT03744910
Phase
PHASE3
Status
Terminated

Conditions

  • Antibody-mediated Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Clazakizumab — BIOLOGICAL
    Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6
  • Physiologic saline solution — DRUG
    Normal saline

Study Details

This trial investigates the efficacy and safety of clazakizumab \[an anti-interleukin (IL)-6 monoclonal antibody (mAb)\] for the treatment of CABMR in recipients of a kidney transplant.

Key Dates

Start date
Oct 14, 2019
Status verified
Jul 2025
Primary completion
Apr 8, 2024
Completion
Apr 8, 2024

Study Design

Enrollment
194 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Clazakizumab
    Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6 that is administered subcutaneously.
  • Placebo Comparator: Placebo
    Physiologic saline solution that is administered subcutaneously.

Primary Outcome Measure

Change From Baseline to Week 52 in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: From Baseline to Week 52 ]

Locations (49)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB) - University of Alabama Hospital (UAB Hospital)BirminghamAlabama35294-
Mayo Clinic HospitalPhoenixArizona85054-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Keck Medical Center Of USCLos AngelesCalifornia90033-
UCLA Kidney Transplant Research ProgramLos AngelesCalifornia90095-
University of California Davis Medical CenterSacramentoCalifornia95817-
California Institute of Renal ResearchSan DiegoCalifornia92123-
North America Research InstituteSan DimasCalifornia91773-
California Pacific Medical CenterSan FranciscoCalifornia94109-
Kaiser PermanenteSan FranciscoCalifornia94118-
University of California, San Francisco Medical CenterSan FranciscoCalifornia94143-
University Of Colorado Hospital - Anschutz Medical CampusAuroraColorado80045-
Tampa General Medical GroupTampaFlorida33606-
Northwestern Memorial HospitalChicagoIllinois60611-
Rush University Medical Center - University Cardiovascular SurgeonsChicagoIllinois60612-
Indiana University (IU) Health Physicians - Kidney Diseases Clinic - Medical Diagnostic Center LocationIndianapolisIndiana46202-
Unity Point HealthDes MoinesIowa50309-
Holden Comprehensive Cancer Center, University of Iowa Hospitals and ClinicsIowa CityIowa52242-
University of Louisville Research FoundationLouisvilleKentucky40202-
Tulane University Health Sciences CenterNew OrleansLouisiana70112-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General Cancer CenterBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
University of MinnesotaMinneapolisMinnesota55455-
Mayo ClinicRochesterMinnesota55095-
Washington University School of Medicine - Infectious Diseases (WU ID) ClinicSt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68105-
Saint Barnabas Medical CenterLivingstonNew Jersey07039-
Erie County Medical Center Corp.BuffaloNew York14215-
Columbia University Medical CenterNew YorkNew York10032-
New York Presbyterian Hospital / Weill Cornell Medical CenterNew YorkNew York10021-
NYU Langone Medical CenterNew YorkNew York10016-
Duke Cancer InstituteDurhamNorth Carolina27710-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
The Ohio State University, Comprehensive Transplant CenterColumbusOhio43210-
University of CincinnatiToledoOhio43614-
Integris Baptist Medical CenterOklahoma CityOklahoma73112-
Lehigh Valley Health NetworkAllentownPennsylvania18103-
Central Pennsylvania Transplant FoundationHarrisburgPennsylvania17104-
Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Rhode Island HospitalProvidenceRhode Island02906-
Renal Disease Research InstituteDallasTexas75204-
UT Southwestern Medical CenterDallasTexas75235-
Methodist Healthcare System of San AntonioSan AntonioTexas78229-
VCU HealthRichmondVirginia23298-
University of WashingtonSeattleWashington98195-
University of Wisconsin School of Medicine and Public Health (UWSMPH)MadisonWisconsin53705-
Medical College of WI Froedtert HospitalMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham (UAB) - University of Alabama Hospital (UAB Hospital)· Birmingham, ALMayo Clinic Hospital· Phoenix, AZCedars-Sinai Medical Center· Los Angeles, CAKeck Medical Center Of USC· Los Angeles, CAUCLA Kidney Transplant Research Program· Los Angeles, CAUniversity of California Davis Medical Center· Sacramento, CA

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