At a glance
ClinicalIndex Comparison Record- ✓Patient with CKD stage 5 (eGFR <15 mL/min and/or on renal replacement therapy) in preparation for kidney transplantation from a live donor
- ✓Patient age ≥18 years and <70 years
- ✓ABO-blood group identical or compatible with donor
- ✓First kidney transplantation
- ✕Preexisting severe psychiatric disorder
- ✕Heart insufficiency NYHA grade III or IV
- ✕Severe liver disease (AST, ALT, or GGT ≥3 x ULN)
- ✕Active infection of HIV, HBV, HCV, EBV, or syphilis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating MIC and Standard of Care for Kidney Transplantation. Currently recruiting, targeting 126 participants across 8 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Single intravenous infusion of 1.5x10exp8 MIC per kg of body weight
No application of the investigational medicinal product MIC