Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
NCT ID: NCT03744910
Last Updated: 2025-07-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
194 participants
INTERVENTIONAL
2019-10-14
2024-04-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Clazakizumab
Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6 that is administered subcutaneously.
Clazakizumab
Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6
Placebo
Physiologic saline solution that is administered subcutaneously.
Physiologic saline solution
Normal saline
Interventions
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Clazakizumab
Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6
Physiologic saline solution
Normal saline
Eligibility Criteria
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Inclusion Criteria
2. Living donor/deceased donor kidney transplant recipients ≥6 months from time of transplant.
3. Diagnosis of CABMR determined by kidney biopsy and the presence of HLA DSA using single-antigen bead-based assays. For eligibility, kidney biopsy must not be older than 12 months and DSA analysis must be performed no longer than 6 months prior to the start of Screening.
NOTE: • Within 3 months prior to the start of Screening, treatments for ABMR or TCMR, with the exception of steroids\*, are not allowed (see Exclusion Criterion 3).
• If treatment for ABMR (including CABMR) or TCMR (other than steroids\*) was given between 3 to 12 months of Screening, a repeat kidney biopsy and DSA analysis are required at least 6 weeks after the end of treatment to confirm continuing CABMR and presence of HLA DSA and to determine eligibility.
\* A maximum dose of 2g of methylprednisolone intravenously (or dose equivalent of other steroids), followed by a taper to the original maintenance steroid dose is allowed.
The following histopathologic and serologic diagnostic criteria (based on Banff 2015 criteria \[Loupy et al, 2017\]) must be met for inclusion:
1. Morphologic evidence of chronic tissue injury, as demonstrated by transplant glomerulopathy (TG) (cg) \> 0). Biopsies without evidence of chronic tissue injury on light microscopy, but with glomerular basement membrane double contours on electron microscopy (cg1a) are eligible.
2. Evidence of current/recent antibody interaction with vascular endothelium, including 1 or more of the following:
i. Linear C4d staining in peritubular capillaries or medullary vasa recta (Banff scores C4d2 or C4d3 by immunofluorescence on frozen sections, or C4d \> 0 by immunohistochemistry on paraffin sections).
ii. At least moderate microvascular inflammation (\[glomerulitis score, g + peritubular capillaritis score, ptc\] ≥ 2) in the absence of recurrent or de novo glomerulonephritis, although in the presence of acute TCMR, borderline infiltrate, or infection, ptc ≥ 2 alone is not sufficient and g must be ≥ 1.
NOTE: The local pathologist's diagnosis must be reviewed by a central pathologist to confirm eligibility for entry into the study. Biopsies with other histopathologic changes (eg, BKV nephropathy or recurrent glomerulonephritis) may be eligible if concurrent CABMR changes (as detailed above) are present and determined to be the predominant cause of renal dysfunction.
c. Serologic evidence of circulating HLA DSA. NOTE: The local laboratory DSA results must be reviewed and confirmed by the central HLA reviewer during the screening period.
4. Written informed consent obtained from subject (or legally acceptable representative) before any trial-related procedures.
Exclusion Criteria
2. Treatment for ABMR (including CABMR) or TCMR within 3 months prior to the start of screening with the exception of steroids.
3. Received T cell depleting agents (e.g., alemtuzumab, anti-thymocyte globulin) within 3 months prior to the start of screening.
4. Pregnant, breastfeeding, or unwillingness to practice adequate contraception.
5. Active tuberculosis (TB) or history of active TB.
6. History of human immunodeficiency virus (HIV) infection or positive for HIV.
7. Seropositive for hepatitis B surface antigen (HBsAg)
8. Hepatitis C virus (HCV) RNA positive.
18 Years
75 Years
ALL
No
Sponsors
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ICON Clinical Research
INDUSTRY
CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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University of Alabama at Birmingham (UAB) - University of Alabama Hospital (UAB Hospital)
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Keck Medical Center Of USC
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA Kidney Transplant Research Program
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
California Institute of Renal Research
San Diego, California, United States
North America Research Institute
San Dimas, California, United States
California Pacific Medical Center
San Francisco, California, United States
Kaiser Permanente
San Francisco, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
University Of Colorado Hospital - Anschutz Medical Campus
Aurora, Colorado, United States
Tampa General Medical Group
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center - University Cardiovascular Surgeons
Chicago, Illinois, United States
Indiana University (IU) Health Physicians - Kidney Diseases Clinic - Medical Diagnostic Center Location
Indianapolis, Indiana, United States
Unity Point Health
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Louisville Research Foundation
Louisville, Kentucky, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Massachusetts General Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine - Infectious Diseases (WU ID) Clinic
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Erie County Medical Center Corp.
Buffalo, New York, United States
NYU Langone Medical Center
New York, New York, United States
New York Presbyterian Hospital / Weill Cornell Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
The Ohio State University, Comprehensive Transplant Center
Columbus, Ohio, United States
University of Cincinnati
Toledo, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Central Pennsylvania Transplant Foundation
Harrisburg, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Renal Disease Research Institute
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States
VCU Health
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin School of Medicine and Public Health (UWSMPH)
Madison, Wisconsin, United States
Medical College of WI Froedtert Hospital
Milwaukee, Wisconsin, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
WSLHD, Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
The University of Queensland - Princess Alexandra Hospital (PAH)
Woolloongabba, Queensland, Australia
Monash Health Monash Medical Centre
Clayton, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Sir Charles Gairdner Hospital (SCGH)
Nedlands, Western Australia, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Royal Prince Alfred Hospital
Camperdown, , Australia
Monash Medical Centre
Clayton, , Australia
Linear Clinical Research
Nedlands, , Australia
Westmead Hospital
Westmead, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
LKH-Universität Hospital Graz
Graz, , Austria
Universitätsklinik für Innere Medizin III Innsbruck
Innsbruck, , Austria
Medizinische Universität Wien, Allgemeines Krankenhaus der S
Vienna, , Austria
UZ Antwerpen
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire Sart Tilman
Liège, , Belgium
Vancouver General Hospital - Gordon & Leslie Diamond Centre
Vancouver, British Columbia, Canada
St. Paul's Hospital, Providence Health Care, Univ. Of British Columbia
Vancouver, British Columbia, Canada
Shared Health Inc. operating as the Health Sciences Centre
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
St. Michael's Health Centre
Toronto, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
St Paul's Hospital Foundation
Saskatoon, Saskatchewan, Canada
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Montreal, , Canada
University Health Network
Toronto, , Canada
Centrum kardiovaskulární a transplantacní chirurgie Brno
Brno střed, , Czechia
Fakultní Nemocnice Olomouc
Olomouc, , Czechia
IKEM
Prague, , Czechia
CHU GRENOBLE ALPES - Consultation Néphrologie Bureau des ARC (Côté Chartreuse, Rez-de-Chaussée Haut)
Grenoble, Grenoble Cédex 09, France
Néphrologie - Pavillon Sainte Venise - CHU de Rouen - Hôpital de Bois Guillaume
Bois-Guillaume, , France
Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, , France
Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor
Créteil, , France
Hopital Kremlin Bicetre
Le Kremlin-Bicêtre, , France
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
Limoges, , France
Hopital Edouard Herriot
Lyon, , France
Hopital de la Conception - APHM
Marseille, , France
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve
Montpellier, , France
CHU de Nantes - Houtel Dieu
Nantes, , France
Centre Hospitalier Universitaire de Nice, Hopital Pasteur 2
Nice, , France
Hospital Saint-Louis - APHP
Paris, , France
Hopital Necker Enfants Malades
Paris, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
Strasbourg, , France
CHU Rangueil
Toulouse, , France
Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau
Tours, , France
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, , Germany
Debreceni Egyetem, Klinikai Központ, Auguszta
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
Amsterdam, , Netherlands
Amsterdam UMC location AMC
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Leiden University Medical Center (LUMC)
Leiden, , Netherlands
Maastricht University Medical Centre
Maastricht, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Pusan National University Hospital
Busan, , South Korea
Keimyung Dongsan Medical Center
Daegu, , South Korea
Asan Medical Center
Seoul, , South Korea
Kangdong Sacred Heart Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Kosin University Gospel Hospital
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Hospital Del Mar
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias
Madrid, , Spain
Hospital Universitario Marques De Valdecilla
Santander, , Spain
Centro Hospital Universitario Dr. Preset
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Karolinska University Hospital
Huddinge, , Sweden
Karolinska University Hospital
Solna, , Sweden
Uppsala Universitet - Akademiska Sjukhuset
Uppsala, , Sweden
Uppsala Universitet - Akademiska Sjukhuset
Uppsala, , Sweden
Hualien Tzu Chi Hospital
Hualien City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taichung Veterans General Hospital
Taichang, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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References
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Mannon RB, Vincenti FG. Poised for Innovation: Considerations for End Points for New Drug Development in Kidney Transplantation. J Am Soc Nephrol. 2024 Nov 1;35(11):1603-1606. doi: 10.1681/ASN.0000000000000475. Epub 2024 Aug 5. No abstract available.
Borski A, Eskandary F, Haindl S, Doberer K, Muhlbacher J, Mayer KA, Budde K, Halloran PF, Chong E, Jilma B, Bohmig GA, Wahrmann M. Anti-interleukin-6 Antibody Clazakizumab in Antibody-mediated Renal Allograft Rejection: Accumulation of Antibody-neutralized Interleukin-6 Without Signs of Proinflammatory Rebound Phenomena. Transplantation. 2023 Feb 1;107(2):495-503. doi: 10.1097/TP.0000000000004285. Epub 2023 Jan 26.
Jordan SC, Ammerman N, Choi J, Huang E, Najjar R, Peng A, Sethi S, Sandhu R, Atienza J, Toyoda M, Ge S, Lim K, Gillespie M, Zhang X, Haas M, Vo A. Evaluation of Clazakizumab (Anti-Interleukin-6) in Patients With Treatment-Resistant Chronic Active Antibody-Mediated Rejection of Kidney Allografts. Kidney Int Rep. 2022 Feb 9;7(4):720-731. doi: 10.1016/j.ekir.2022.01.1074. eCollection 2022 Apr.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003682-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VKTX01
Identifier Type: OTHER
Identifier Source: secondary_id
CSL300_3001
Identifier Type: -
Identifier Source: org_study_id
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