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 (≥ 60 days) 40% decline in eGFR from Baseline. \*total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m2 AND / OR dialysis ≥ 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 ≥ 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
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Rush University Medical Center - University Cardiovascular Surgeons
🇺🇸Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Washington
🇺🇸Seattle, Washington, United States
Indiana University (IU) Health Physicians - Kidney Diseases Clinic - Medical Diagnostic Center Location
🇺🇸Indianapolis, Indiana, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Methodist Healthcare System of San Antonio
🇺🇸San Antonio, Texas, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of California, San Francisco Medical Center
🇺🇸San Francisco, California, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Alabama at Birmingham (UAB) - University of Alabama Hospital (UAB Hospital)
🇺🇸Birmingham, Alabama, United States
Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor
🇫🇷Créteil, France
Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
🇫🇷Strasbourg, France
CHU Rangueil
🇫🇷Toulouse, France
Massachusetts General Cancer Center
🇺🇸Boston, Massachusetts, United States
UCLA Kidney Transplant Research Program
🇺🇸Los Angeles, California, United States
Kaiser Permanente
🇺🇸San Francisco, California, United States
North America Research Institute
🇺🇸San Dimas, California, United States
California Institute of Renal Research
🇺🇸San Diego, California, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Erie County Medical Center Corp.
🇺🇸Buffalo, New York, United States
New York Presbyterian Hospital / Weill Cornell Medical Center
🇺🇸New York, New York, United States
The Ohio State University, Comprehensive Transplant Center
🇺🇸Columbus, Ohio, United States
Washington University School of Medicine - Infectious Diseases (WU ID) Clinic
🇺🇸Saint Louis, Missouri, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia
The University of Queensland - Princess Alexandra Hospital (PAH)
🇦🇺Woolloongabba, Queensland, Australia
Renal Disease Research Institute
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Hopital Kremlin Bicetre
🇫🇷Le Kremlin-Bicêtre, France
Sir Charles Gairdner Hospital (SCGH)
🇦🇺Nedlands, Western Australia, Australia
Hopital de la Conception - APHM
🇫🇷Marseille, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, France
Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau
🇫🇷Tours Cedex 9, France
IKEM
🇨🇿Prague, Czechia
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
St. Michael's Health Centre
🇨🇦Toronto, Ontario, Canada
Monash Medical Centre
🇦🇺Clayton, Australia
Kosin University Gospel Hospital
🇰🇷Seoul, Korea, Republic of
Hopital Necker Enfants Malades
🇫🇷Paris, France
Linear Clinical Research
🇦🇺Nedlands, Australia
UZ Antwerpen
🇧🇪Edegem, Belgium
Westmead Hospital
🇦🇺Westmead, Australia
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve
🇫🇷Montpellier, France
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
🇩🇪Berlin, Germany
Centrum kardiovaskulární a transplantacní chirurgie Brno
🇨🇿Brno Střed, Czechia
Hopital Edouard Herriot
🇫🇷Lyon, France
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
CHU GRENOBLE ALPES - Consultation Néphrologie Bureau des ARC (Côté Chartreuse, Rez-de-Chaussée Haut)
🇫🇷Grenoble, Grenoble Cédex 09, France
Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
🇫🇷Limoges Cedex, France
CHU de Nantes - Houtel Dieu
🇫🇷Nantes Cedex 1, France
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
🇨🇦Montréal, Canada
Fakultní Nemocnice Olomouc
🇨🇿Olomouc, Czechia
Hospital Saint-Louis - APHP
🇫🇷Paris, France
Keimyung Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Karolinska University Hospital
🇸🇪Solna, Sweden
Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias
🇪🇸Madrid, Spain
Auckland City Hospital
🇳🇿Auckland, New Zealand
Hospital Del Mar
🇪🇸Barcelona, Spain
Radboud UMC
🇳🇱Nijmegen, Netherlands
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
Centro Hospital Universitario Dr. Preset
🇪🇸Valencia, Spain
Uppsala Universitet - Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University Health Network
🇨🇦Toronto, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Cincinnati
🇺🇸Toledo, Ohio, United States
Seoul National University Bundang Hospital
🇰🇷Seoul, Korea, Republic of
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
University Of Colorado Hospital - Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Tampa General Medical Group
🇺🇸Tampa, Florida, United States
University of Louisville Research Foundation
🇺🇸Louisville, Kentucky, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Central Pennsylvania Transplant Foundation
🇺🇸Harrisburg, Pennsylvania, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, Australia
Medical College of WI Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
WSLHD, Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Shared Health Inc. operating as the Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Néphrologie - Pavillon Sainte Venise - CHU de Rouen - Hôpital de Bois Guillaume
🇫🇷Bois-Guillaume, France
Centre Hospitalier Universitaire de Nice, Hopital Pasteur 2
🇫🇷Nice Cedex 1, France
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
🇳🇱Amsterdam, Netherlands
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Marques De Valdecilla
🇪🇸Santander, Spain
Centre Hospitalier Universitaire Sart Tilman
🇧🇪Liège, Belgium
McGill University Health Center
🇨🇦Montréal, Quebec, Canada
Leiden University Medical Center (LUMC)
🇳🇱Leiden, Netherlands
Monash Health Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
St. Paul's Hospital, Providence Health Care, Univ. Of British Columbia
🇨🇦Vancouver, British Columbia, Canada
UZ Leuven
🇧🇪Leuven, Belgium
Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
Hualien Tzu Chi Hospital
🇨🇳Hualien City, Taiwan
Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
The Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
LKH-Universität Hospital Graz
🇦🇹Graz, Austria
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Debreceni Egyetem, Klinikai Központ, Auguszta
🇭🇺Debrecen, Hungary
Amsterdam UMC location AMC
🇳🇱Amsterdam, Netherlands
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
NYU Langone Medical Center
🇺🇸New York, New York, United States
Universitätsklinik für Innere Medizin III Innsbruck
🇦🇹Innsbruck, Austria
Maastricht University Medical Centre
🇳🇱Maastricht, Netherlands
St Paul's Hospital Foundation
🇨🇦Saskatoon, Saskatchewan, Canada
Medizinische Universität Wien, Allgemeines Krankenhaus der S
🇦🇹Vienna, Austria
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
Taichung Veterans General Hospital
🇨🇳Taichang, Taiwan
Vancouver General Hospital - Gordon & Leslie Diamond Centre
🇨🇦Vancouver, British Columbia, Canada
Unity Point Health
🇺🇸Des Moines, Iowa, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
VCU Health
🇺🇸Richmond, Virginia, United States
University of Wisconsin School of Medicine and Public Health (UWSMPH)
🇺🇸Madison, Wisconsin, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada