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Detail of the clinical trial

Title of the trial A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-Mediated Rejection in Kidney Transplant Recipients
EudraCT number 2018-003682-34
Protocol number VKTX01
Sponsor CSL Behring LLC, 1020 First Avenue, Kung of Prissia, PA 19406, United States of America
Indications Transplantology (organs)
Diagnosis Treatment of Chronic Active Antibody - Mediated Rejection in Kidney Transplant Recipients
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2019
Date of approval by Institute (SÚKL) 23.10.2019
Date of approval by EC 19. 6. 2019
Date of initiation CT in ČR 27. 1. 2020
Date of ending CT in ČR
Sites Fakultní nemocnice Olomouc, III. interní klinika - nefrologická, revmatologická a endokrinologická, Zdravotníků 248/7, 779 00 Olomouc
Institut klinické a experimentální medicíny,Klinika nefrologie,Vídeňská 1958/9,Praha 4,140 21

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