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) Male Female Patients |
| 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 | |
| Notice | |
| 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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