Condition: Kidney Transplantation · Sponsor: TolerogenixX GmbH
In this clinical trial the investigational medicinal product MIC is to be examined for its efficacy and safety in patients with living kidney transplantation. For this purpose the patients participating in the clinical trial and their associated kidney donors are randomly assigned to one of three treatment groups during the screening procedure. For the production of the investigational medicinal product MIC for the patients in the MIC therapy group mononuclear cells of the peripheral blood are obtained from the donors in a leukapheresis procedure. In the subsequent treatment phase, the patients in the MIC therapy group receive MIC as a weight-adjusted single dose administered intravenously. As part of the 12-month follow-up phase the kidney transplant and the corresponding immunosuppressive therapy will take place seven days later. Patients in the control group will receive a conventional standard immunosuppressive regimen without prior administration of the investigational medicinal product MIC after kidney transplantation. All patients taking part in this clinical trial are followed up for one year after kidney transplantation with regard to the efficacy and safety of MIC in regular visits at their study site. As the investigational medicinal product is an advanced therapy medicinal product (ATMP) all subjects will be monitored for a further 2 years after the end of the follow-up phase of the clinical trial. A total of 63 transplant pairs, consisting of donor and transplan…
This description comes directly from the study's public registry record.
Matthias Schaier, Prof.Dr.med. · +49 162 2638 005 · schaier@tolerogenixx.com
Always discuss trial participation with your own doctor first.
| Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin Charité - Universitätsmedizin Berlin | Berlin, Germany | Not Yet Recruiting |
| Universitätsklinikum Hamburg-Eppendorf, Universitäres Transplantations Centrum | Hamburg, Germany | Recruiting |
| Innere Medizin V; Klinik für Hämatologie, Onkologie, Rheumatologie; Universitätsklinikum Heidelberg | Heidelberg, Germany | Recruiting |
| Medizinische Klinik, Innere Medizin X Nephrologie - Nierenzentrum Universitätsklinikum Heidelberg | Heidelberg, Germany | Recruiting |
| Transplantationszentrum München; Ludwig-Maximilians-Universität | Munich, Germany | Recruiting |
| Klinikum rechts der Isar, Abteilung Nephrologie, Technische Universität München | Munich, Germany | Not Yet Recruiting |
| Universitätsklinikum Münster, Transplantationsnephrologie | Münster, Germany | Recruiting |
| Klinik für Nieren-, Hochdruck- und Autoimmunerkrankungen; Transplantationszentrum Stuttgart | Stuttgart, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05365672