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Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:
An Open, Randomized-controlled, Multi-center Phase-II Clinical Trial of Individualized Immunosuppression With Intravenously Administered Donor Modified Immune Cells (MIC) Compared to Standard-of-care in Living Donor Kidney Transplantation

Clinical Trial Summary

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 transplant recipient, are to be included in the clinical trial. The 63 patients will be randomized 2:1 to be treated with MIC (MIC group) or without MIC (control group). Additionally, low immunosuppression or minimal immunosuppression treatments will be used in the patients in the MIC group.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05365672
Study type Interventional
Source TolerogenixX GmbH
Contact Matthias Schaier, Prof.Dr.med.
Phone +49 162 2638 005
Email schaier@tolerogenixx.com
Status Recruiting
Phase Phase 2
Start date May 4, 2022
Completion date June 2027
View Details
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