Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
- Conditions
- Antibody-mediated Rejection
- Interventions
- Biological: ClazakizumabDrug: Physiologic saline solution
- Registration Number
- NCT03744910
- Lead Sponsor
- CSL Behring
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 194
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clazakizumab Clazakizumab Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6 that is administered subcutaneously. Placebo Physiologic saline solution Physiologic saline solution that is administered subcutaneously.
- Primary Outcome Measures
Name Time Method Time to composite all-cause allograft loss or irreversible loss of allograft function Up to approximately 8 years Defined as time to first occurrence of any of the following components:
* eGFR \< 15 mL/min/1.73 m2\*,
* return to dialysis\*,
* allograft nephrectomy,
* retransplantation,
* death from any cause, or
* a sustained (โฅ 60 days) 40% decline in eGFR from Baseline. \*total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m2 AND / OR dialysis โฅ 60 days.
If the eGFR \< 15 mL/min/1.73 m2 is the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after โฅ 60 days from the first measurement.
The primary efficacy endpoint will be analyzed as part of the final analysis when at least 221 composite all-cause allograft loss or irreversible loss of allograft function events have occurred.
- Secondary Outcome Measures
Name Time Method Incidence of composite all-cause allograft loss or irreversible loss of allograft function Up to approximately 8 years Change in mean estimated glomerular filtration rate (eGFR) from Baseline to End of Treatment (EOT) Baseline and up to approximately 8 years Trough concentrations (Ctrough, Ctrough ss) of CSL300 Up to 21 days Incidence and time to death-censored allograft loss Up to approximately 8 years Incidence of acute rejection episodes of T cell-mediated rejection(TCMR) and Antibody-mediated rejection (ABMR) from Baseline to EOT Baseline and up to 8 years Overall patient survival Up to approximately 8 years Time to composite all-cause allograft loss Baseline and up to approximately 8 years Incidence and time to irreversible loss of allograft function Baseline and up to approximately 8 years Change in spot urine albumin creatinine ratio (UACR) from Baseline to EOT Baseline and up to approximately 8 years Change in (Donor-specific antibodies) DSA titers and Mean fluorescence intensity (MFI) scores from Baseline to EOT Baseline and up to approximately 8 years Change in Banff lesion grading score (2015 criteria [Loupy et al, 2017]) of pre-treatment to post-treatment (Week 52) kidney biopsies Up to 52 weeks Maximum concentration (Cmax, Cmax ss) of CSL300 Up to 21 days Area under the concentration-time curve (AUC0-tau) at steady state of CSL300 Up to 21 days Time of maximum concentration (Tmax, Tmax ss) of CSL300 Up to 21 days
Trial Locations
- Locations (138)
Keck Medical Center Of USC
๐บ๐ธLos Angeles, California, United States
Cedars-Sinai Medical Center
๐บ๐ธLos Angeles, California, United States
Rush University Medical Center - University Cardiovascular Surgeons
๐บ๐ธChicago, Illinois, United States
Beth Israel Deaconess Medical Center
๐บ๐ธBoston, Massachusetts, United States
University of Pennsylvania
๐บ๐ธPhiladelphia, Pennsylvania, United States
University of Washington
๐บ๐ธSeattle, Washington, United States
Indiana University (IU) Health Physicians - Kidney Diseases Clinic - Medical Diagnostic Center Location
๐บ๐ธIndianapolis, Indiana, United States
University of Minnesota
๐บ๐ธMinneapolis, Minnesota, United States
Methodist Healthcare System of San Antonio
๐บ๐ธSan Antonio, Texas, United States
California Pacific Medical Center
๐บ๐ธSan Francisco, California, United States
University of California, San Francisco Medical Center
๐บ๐ธSan Francisco, California, United States
Saint Barnabas Medical Center
๐บ๐ธLivingston, New Jersey, United States
Mayo Clinic Hospital
๐บ๐ธPhoenix, Arizona, United States
Integris Baptist Medical Center
๐บ๐ธOklahoma City, Oklahoma, United States
University of Alabama at Birmingham (UAB) - University of Alabama Hospital (UAB Hospital)
๐บ๐ธBirmingham, Alabama, United States
Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor
๐ซ๐ทCrรฉteil, France
Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
๐ซ๐ทStrasbourg, France
CHU Rangueil
๐ซ๐ทToulouse, France
Massachusetts General Cancer Center
๐บ๐ธBoston, Massachusetts, United States
UCLA Kidney Transplant Research Program
๐บ๐ธLos Angeles, California, United States
Kaiser Permanente
๐บ๐ธSan Francisco, California, United States
North America Research Institute
๐บ๐ธSan Dimas, California, United States
California Institute of Renal Research
๐บ๐ธSan Diego, California, United States
Henry Ford Health System
๐บ๐ธDetroit, Michigan, United States
Erie County Medical Center Corp.
๐บ๐ธBuffalo, New York, United States
New York Presbyterian Hospital / Weill Cornell Medical Center
๐บ๐ธNew York, New York, United States
The Ohio State University, Comprehensive Transplant Center
๐บ๐ธColumbus, Ohio, United States
Washington University School of Medicine - Infectious Diseases (WU ID) Clinic
๐บ๐ธSaint Louis, Missouri, United States
Lehigh Valley Health Network
๐บ๐ธAllentown, Pennsylvania, United States
Princess Alexandra Hospital
๐ฆ๐บWoolloongabba, Australia
The University of Queensland - Princess Alexandra Hospital (PAH)
๐ฆ๐บWoolloongabba, Queensland, Australia
Renal Disease Research Institute
๐บ๐ธDallas, Texas, United States
UT Southwestern Medical Center
๐บ๐ธDallas, Texas, United States
Hopital Kremlin Bicetre
๐ซ๐ทLe Kremlin-Bicรชtre, France
Sir Charles Gairdner Hospital (SCGH)
๐ฆ๐บNedlands, Western Australia, Australia
Hopital de la Conception - APHM
๐ซ๐ทMarseille, France
Centre Hospitalier Universitaire de Poitiers
๐ซ๐ทPoitiers, France
Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau
๐ซ๐ทTours Cedex 9, France
IKEM
๐จ๐ฟPrague, Czechia
Korea University Anam Hospital
๐ฐ๐ทSeoul, Korea, Republic of
St. Michael's Health Centre
๐จ๐ฆToronto, Ontario, Canada
Monash Medical Centre
๐ฆ๐บClayton, Australia
Kosin University Gospel Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Hopital Necker Enfants Malades
๐ซ๐ทParis, France
Linear Clinical Research
๐ฆ๐บNedlands, Australia
UZ Antwerpen
๐ง๐ชEdegem, Belgium
Westmead Hospital
๐ฆ๐บWestmead, Australia
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve
๐ซ๐ทMontpellier, France
Asan Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
๐ฉ๐ชBerlin, Germany
Centrum kardiovaskulรกrnรญ a transplantacnรญ chirurgie Brno
๐จ๐ฟBrno Stลed, Czechia
Hopital Edouard Herriot
๐ซ๐ทLyon, France
Kyung Hee University Hospital at Gangdong
๐ฐ๐ทSeoul, Korea, Republic of
CHU GRENOBLE ALPES - Consultation Nรฉphrologie Bureau des ARC (Cรดtรฉ Chartreuse, Rez-de-Chaussรฉe Haut)
๐ซ๐ทGrenoble, Grenoble Cรฉdex 09, France
Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin
๐ซ๐ทBordeaux, France
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
๐ซ๐ทLimoges Cedex, France
CHU de Nantes - Houtel Dieu
๐ซ๐ทNantes Cedex 1, France
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
๐จ๐ฆMontrรฉal, Canada
Fakultnรญ Nemocnice Olomouc
๐จ๐ฟOlomouc, Czechia
Hospital Saint-Louis - APHP
๐ซ๐ทParis, France
Keimyung Dongsan Medical Center
๐ฐ๐ทDaegu, Korea, Republic of
Samsung Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Karolinska University Hospital
๐ธ๐ชSolna, Sweden
Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias
๐ช๐ธMadrid, Spain
Auckland City Hospital
๐ณ๐ฟAuckland, New Zealand
Hospital Del Mar
๐ช๐ธBarcelona, Spain
Radboud UMC
๐ณ๐ฑNijmegen, Netherlands
Hospital Clinic Barcelona
๐ช๐ธBarcelona, Spain
Centro Hospital Universitario Dr. Preset
๐ช๐ธValencia, Spain
Uppsala Universitet - Akademiska Sjukhuset
๐ธ๐ชUppsala, Sweden
Mayo Clinic
๐บ๐ธRochester, Minnesota, United States
University of Nebraska Medical Center
๐บ๐ธOmaha, Nebraska, United States
University Health Network
๐จ๐ฆToronto, Canada
London Health Sciences Centre
๐จ๐ฆLondon, Ontario, Canada
Kangdong Sacred Heart Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Severance Hospital Yonsei University
๐ฐ๐ทSeoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Pusan National University Yangsan Hospital
๐ฐ๐ทYangsan, Korea, Republic of
Hospital Universitario Miguel Servet
๐ช๐ธZaragoza, Spain
Hospital Universitari de Bellvitge
๐ช๐ธBarcelona, Spain
Duke Cancer Institute
๐บ๐ธDurham, North Carolina, United States
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
๐บ๐ธIowa City, Iowa, United States
University of Cincinnati
๐บ๐ธToledo, Ohio, United States
Seoul National University Bundang Hospital
๐ฐ๐ทSeoul, Korea, Republic of
University of California Davis Medical Center
๐บ๐ธSacramento, California, United States
University Of Colorado Hospital - Anschutz Medical Campus
๐บ๐ธAurora, Colorado, United States
Tampa General Medical Group
๐บ๐ธTampa, Florida, United States
University of Louisville Research Foundation
๐บ๐ธLouisville, Kentucky, United States
Wake Forest University Health Sciences
๐บ๐ธWinston-Salem, North Carolina, United States
Columbia University Medical Center
๐บ๐ธNew York, New York, United States
Jefferson University Hospital
๐บ๐ธPhiladelphia, Pennsylvania, United States
Central Pennsylvania Transplant Foundation
๐บ๐ธHarrisburg, Pennsylvania, United States
Royal Prince Alfred Hospital
๐ฆ๐บCamperdown, Australia
Medical College of WI Froedtert Hospital
๐บ๐ธMilwaukee, Wisconsin, United States
WSLHD, Westmead Hospital
๐ฆ๐บWestmead, New South Wales, Australia
Royal Adelaide Hospital
๐ฆ๐บAdelaide, Australia
Shared Health Inc. operating as the Health Sciences Centre
๐จ๐ฆWinnipeg, Manitoba, Canada
Nรฉphrologie - Pavillon Sainte Venise - CHU de Rouen - Hรดpital de Bois Guillaume
๐ซ๐ทBois-Guillaume, France
Centre Hospitalier Universitaire de Nice, Hopital Pasteur 2
๐ซ๐ทNice Cedex 1, France
Pusan National University Hospital
๐ฐ๐ทBusan, Korea, Republic of
Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
๐ณ๐ฑAmsterdam, Netherlands
Seoul National University Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Hospital Universitario Ramon y Cajal
๐ช๐ธMadrid, Spain
Hospital Clinico San Carlos
๐ช๐ธMadrid, Spain
Hospital Vall d'Hebron
๐ช๐ธBarcelona, Spain
Hospital Universitario Marques De Valdecilla
๐ช๐ธSantander, Spain
Centre Hospitalier Universitaire Sart Tilman
๐ง๐ชLiรจge, Belgium
McGill University Health Center
๐จ๐ฆMontrรฉal, Quebec, Canada
Leiden University Medical Center (LUMC)
๐ณ๐ฑLeiden, Netherlands
Monash Health Monash Medical Centre
๐ฆ๐บClayton, Victoria, Australia
St. Paul's Hospital, Providence Health Care, Univ. Of British Columbia
๐จ๐ฆVancouver, British Columbia, Canada
UZ Leuven
๐ง๐ชLeuven, Belgium
Erasmus University Medical Center
๐ณ๐ฑRotterdam, Netherlands
Hualien Tzu Chi Hospital
๐จ๐ณHualien City, Taiwan
Linkou Chang Gung Memorial Hospital
๐จ๐ณTaoyuan, Taiwan
The Royal Melbourne Hospital
๐ฆ๐บParkville, Victoria, Australia
National Taiwan University Hospital
๐จ๐ณTaipei, Taiwan
LKH-Universitรคt Hospital Graz
๐ฆ๐นGraz, Austria
Northwestern Memorial Hospital
๐บ๐ธChicago, Illinois, United States
Debreceni Egyetem, Klinikai Kรถzpont, Auguszta
๐ญ๐บDebrecen, Hungary
Amsterdam UMC location AMC
๐ณ๐ฑAmsterdam, Netherlands
Far Eastern Memorial Hospital
๐จ๐ณNew Taipei City, Taiwan
NYU Langone Medical Center
๐บ๐ธNew York, New York, United States
Universitรคtsklinik fรผr Innere Medizin III Innsbruck
๐ฆ๐นInnsbruck, Austria
Maastricht University Medical Centre
๐ณ๐ฑMaastricht, Netherlands
St Paul's Hospital Foundation
๐จ๐ฆSaskatoon, Saskatchewan, Canada
Medizinische Universitรคt Wien, Allgemeines Krankenhaus der S
๐ฆ๐นVienna, Austria
Debreceni Egyetem Klinikai Kozpont
๐ญ๐บDebrecen, Hungary
University Medical Center Groningen
๐ณ๐ฑGroningen, Netherlands
Universitair Medisch Centrum Utrecht
๐ณ๐ฑUtrecht, Netherlands
Taichung Veterans General Hospital
๐จ๐ณTaichang, Taiwan
Vancouver General Hospital - Gordon & Leslie Diamond Centre
๐จ๐ฆVancouver, British Columbia, Canada
Unity Point Health
๐บ๐ธDes Moines, Iowa, United States
Tulane University Health Sciences Center
๐บ๐ธNew Orleans, Louisiana, United States
VCU Health
๐บ๐ธRichmond, Virginia, United States
University of Wisconsin School of Medicine and Public Health (UWSMPH)
๐บ๐ธMadison, Wisconsin, United States
Rhode Island Hospital
๐บ๐ธProvidence, Rhode Island, United States
Queen Elizabeth II Health Sciences Centre
๐จ๐ฆHalifax, Nova Scotia, Canada