Actively Recruiting
Led by TolerogenixX GmbH · Updated on 2025-04-11
126
Participants Needed
8
Research Sites
104 weeks
Total Duration
T
TolerogenixX GmbH
Lead Sponsor
F
FGK Clinical Research GmbH
Collaborating Sponsor
Researchers are evaluating the safety and effectiveness of an investigational medicine called MIC in patients undergoing living donor kidney transplantation. This Phase II clinical trial involves 63 pairs of donors and recipients randomly assigned to one of three groups. The purpose is to compare MIC therapy combined with different immunosuppressive regimens against standard care to see if MIC can improve transplant outcomes and reduce rejection risks. Patients in the MIC groups receive MIC as a single intravenous dose based on body weight, prepared from donor blood cells collected through leukapheresis. Two MIC treatment arms use different levels of immunosuppression with gradual reduction of medications like tacrolimus and corticosteroids. The control group receives standard immunosuppressive treatment without MIC. Following transplantation, all patients are monitored for one year, followed by an additional two years of safety observation. Participants will have regular visits during the 12-month follow-up to assess kidney function, immune responses, infection rates, and quality of life through lab tests, biopsies, and questionnaires. Researchers will track outcomes such as rejection episodes, antibody development, survival rates, and medication use. Long-term monitoring will continue for two years post-trial to evaluate ongoing safety and transplant health.
CONDITIONS
Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 367 days post MIC infusion
Participants receive a single intravenous infusion of donor modified immune cells (MIC) plus immunosuppression or standard care immunosuppression following kidney transplantation.
Multiple visits including days 0, 5, 6, 7, 37, 97, 142, 183, 187, 277, and 367 post infusion
Duration - Up to 3 years after transplantation
Participants are monitored for safety, kidney graft function, immune response, and adverse events after treatment.
Assessments at multiple time points including months 24 and 36 post infusion
Total: 8 locations
1
Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Not Yet Recruiting
2
Universitätsklinikum Hamburg-Eppendorf, Universitäres Transplantations Centrum
Hamburg, Germany, 20246
Actively Recruiting
3
Innere Medizin V; Klinik für Hämatologie, Onkologie, Rheumatologie; Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
4
Medizinische Klinik, Innere Medizin X Nephrologie - Nierenzentrum Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
5
Transplantationszentrum München; Ludwig-Maximilians-Universität
Munich, Germany, 81377
Actively Recruiting
6
Klinikum rechts der Isar, Abteilung Nephrologie, Technische Universität München
Munich, Germany, 81675
Not Yet Recruiting
7
Universitätsklinikum Münster, Transplantationsnephrologie
Münster, Germany, 48149
Actively Recruiting
8
Klinik für Nieren-, Hochdruck- und Autoimmunerkrankungen; Transplantationszentrum Stuttgart
Stuttgart, Germany, 70174
Actively Recruiting
M
Matthias Schaier, Prof.Dr.med.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Christian Morath, Anita Schmitt, Michael Schmitt...
https://pubmed.ncbi.nlm.nih.gov/36368749