Actively Recruiting
Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation
Led by TolerogenixX GmbH · Updated on 2025-04-11
126
Participants Needed
8
Research Sites
343 weeks
Total Duration
On this page
Sponsors
T
TolerogenixX GmbH
Lead Sponsor
F
FGK Clinical Research GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Donors must be 18 years or older and able to consent
- Donors must understand the trial and provide written consent before any procedures
- Patients must have stage 5 chronic kidney disease or be on renal replacement therapy and preparing for a living donor kidney transplant
- Patients must be between 18 and 69 years old
- Patients must have ABO blood group identical or compatible with their donor
- Patients must be receiving their first kidney transplant
- Patients must have less than 20% panel reactive antibodies by complement dependent cytotoxicity
- Patients must have no detectable donor-specific HLA antibodies by Luminex assay (MFI ≤1000)
- Patients must have a negative CDC crossmatch with the donor
- Patients must test negative for SARS-CoV-2 at screening
- Patients' living donors must provide written consent for trial participation
- Patients must understand the trial and provide written informed consent before any procedures
- Female patients of childbearing potential must have a negative pregnancy test at screening
- Female patients must agree to abstain from heterosexual contact or use two highly effective contraceptive methods during the trial, or be postmenopausal or surgically sterile
- Female patients must agree to abstain from breastfeeding during the trial
- Male patients must agree to true abstinence or use condoms during sexual contact with pregnant women or women of childbearing potential during the trial and for 90 days after mycophenolic acid treatment
You will not qualify if you...
- Donors who are pregnant or breastfeeding
- Donors who participated in another interventional clinical trial within 30 days prior to screening or are in a competing study observation period
- Donors with severe psychiatric, cardiovascular (NYHA III or IV), neurological, liver, or kidney diseases
- Donors with acute or chronic diseases posing risk during leukapheresis
- Donors with malignant neoplasms except completely removed in situ carcinoma
- Donors with known infections (HIV, hepatitis B, C, E, West Nile virus during season, gonorrhea, syphilis) or risk of transmission
- Donors with active infections affecting safety
- Donors with certain known infections or transmissible diseases unless cured for specified periods
- Donors requiring systemic immunosuppressive therapy or with autoimmune diseases
- Donors with immunosuppressive therapy within 6 months prior to screening
- Donors with known substance abuse
- Donors with unexplained symptoms such as night sweats, fever, weight loss, cough, diarrhea, skin lesions, lymph gland swelling, or thrush
- Donors with prior dura mater or cornea grafts, organ transplants, xenotransplants, or pituitary hormones of human origin
- Donors with long stays or operations in the UK during specified periods
- Donors with recent invasive procedures or blood exposure within 4 months prior to screening
- Donors positive for SARS-CoV-2 at screening
- Donors with low hemoglobin, thrombocytes, or leukocytes
- Donors with hypersensitivity to leukapheresis components
- Donors deemed unsuitable by leukapheresis physician
- Patients with severe psychiatric disorder
- Patients with heart insufficiency NYHA III or IV
- Patients with severe liver disease
- Patients with active infection of HIV, hepatitis B, C, EBV, or syphilis
- Patients with active infections affecting safety
- Patients negative for EBV antibodies unless donor is EBV negative
- Patients with recent malignant disease except certain skin cancers
- Patients with immunosuppressive therapy within 6 months prior to screening
- Patients with vasculitis or collagenosis
- Patients with irregular antibodies in Coombs test
- Patients vaccinated within 4 weeks prior to screening
- Patients without spleen
- Patients with substance abuse
- Patients who are pregnant or breastfeeding
- Female patients who have a child with or were pregnant from the donor
- Patients with hypersensitivity to MIC components
- Patients deemed unsuitable by investigator
- Patients who participated in another interventional trial within 30 days or competing study
- Employees or relatives of sponsor or investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
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
Research Team
M
Matthias Schaier, Prof.Dr.med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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