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New treatment option for Kidney Transplantation
Official title Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation
ClinicalTrials.gov ID: NCT05365672
What this study is testing
What is MIC?
MIC is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for kidney transplantation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- Donors:
- Age ≥18 years and able to consent
- Ability to understand the nature and scope of the clinical trial
- Written consent form given prior to any trial-related procedures (including PBMC donation) Patients:
- Patient with CKD in stage 5 (e.g., estimated glomerular filtration rate [eGFR] \<15 mL/min and/or on renal replacement therapy), who are in...
You likely can't join if
- Donors:
- Pregnant or breastfeeding
- Participation in an treatment clinical trial within 30 days prior to Screening or in observation period of a competing study
- Severe psychiatric disease
- Severe cardiovascular diseases (i.e., heart insufficiency of grade NYHA III or IV)
- Severe neurological diseases
See the full eligibility criteria
Who can join
- Donors:
- Age ≥18 years and able to consent
- Ability to understand the nature and scope of the clinical trial
- Written consent form given prior to any trial-related procedures (including PBMC donation) Patients:
- Patient with CKD in stage 5 (e.g., estimated glomerular filtration rate [eGFR] \<15 mL/min and/or on renal replacement therapy), who are in preparation for kidney transplantation from a live donor
- Age ≥18 years, \<70 years
- ABO-blood group identical or compatible with donor
- First kidney transplantation
- Complement dependent cytotoxicity (CDC)-panel reactive antibodies \<20%
- No detection of a donor-specific HLA-antibody in the Luminex-Assay (cutoff: mean fluorescence intensity [MFI] ≤1,000)
- Negative CDC crossmatch with the donor
- Negative PCR test result for severe acute respiratory syndrome coronavirus-2 (SARSCoV-2) at Screening
- Patient's living donor gave written consent for trial participation
- Ability to understand the nature and scope of the clinical trial
- Written informed consent given prior to any trial-related procedures
- Female patients of childbearing potential must:
- have a negative pregnancy test (blood) at Screening.
- either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, 2 highly effective measures of contraception control (failure rate less than 1% per year when used consistently and...
- agree to abstain from breast feeding during the trial participation.
- Male patients must practice true abstinence or agree to use a condom during sexual contact with a pregnant woman or a woman of childbearing potential during the trial participation and for at least 90 days after the end...
What rules you out
- Donors:
- Pregnant or breastfeeding
- Participation in an treatment clinical trial within 30 days prior to Screening or in observation period of a competing study
- Severe psychiatric disease
- Severe cardiovascular diseases (i.e., heart insufficiency of grade NYHA III or IV)
- Severe neurological diseases
- Severe liver or kidney diseases
- Any acute or chronic disease that may put the donor at risk in case of cell donation by leukapheresis
- Malignant neoplasms, except in situ carcinoma after complete removal
- Known infections or exposures to human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis E virus, West Nile virus (WNV; testing only required during WNV season [June 1st to...
- Active bacterial, mycotic or viral infection, except active infections that, in the investigator's opinion, do not affect patient safety (e.g., foot fungus, nail fungus, or common warts)
- Known malaria infection; known infection of tuberculosis, Q fever, Salmonella typhi and paratyphi, or osteomyelitis (if not medically documented to have been cured for 2 years); known toxoplasmosis (except if symptom...
- Known transmissible spongiform encephalopathies
- Known protozoonosis (babesiosis, trypanosomiasis [e.g., chagas], leishmaniosis), known chronic bacterial infections as brucellosis, rickettsiosis, leprosy, relapsing fever, melioidosis, tularemia (except after assured...
- Autoimmune diseases requiring systemic immunosuppressive therapy
- Allergies requiring systemic immunosuppressive therapy
- Immunosuppressive therapy within 6 months prior screening
- Known or suspected abuse of alcohol, drugs, or medicinal products
- Unexplained night sweats, unexplained fever, unexplained weight loss, prolonged unexplained cough or diarrhea, unexplained skin lesions, lymph gland swelling or thrush
- Dura mater and/or cornea grafts, allogeneic organ transplants, xenotransplants, pituitary hormones of human origin received
- Stay of longer than 6 months in the United Kingdom between 1980 and 1996 and/or an operation and/or blood transfusion in the United Kingdom after 01-Jan-1980
- Operations or other invasive interventions (e.g., endoscopies, biopsies, catheter applications, acupunctures [except acupuncture with sterile and/or disposable needles]) within 4 months prior to Screening
- Any invasive exposure to blood (i.e., allogeneic blood components or plasma derivatives) or blood-contaminated injection needles or instruments, tattoos or piercings within 4 months prior to Screening
- Positive PCR test result for SARS-CoV-2 at Screening
- Hemoglobin \<8.0 g/dL, thrombocytes \<80,000/μL and/or leukocytes \<3,000/μL
- Known history of hypersensitivity to components used in the leukapheresis setting (i.e., components of the anticoagulant acid citrate dextrose solution)
- Any finding or medical condition prohibiting the inclusion in the trial according to the judgment of the responsible leukapheresis physician (including assessment of the suitability of the veins for leukapheresis by the...
- Preexisting severe psychiatric disorder
- Heart insufficiency of grade NYHA III or IV
- Severe liver disease (aspartate aminotransferase or alanine aminotransferase or gamma glutamyl transpeptidase ≥3 x ULN)
- Active infection of HIV, HBV, HCV, EBV or syphilis
- Active bacterial, mycotic, or viral infection, except active infections that, in the investigator's opinion, do not affect patient safety (e.g., foot fungus, nail fungus, or common warts)
- Negative serological test result for antibodies specific for Epstein-Barr virus (EBV) antigens (Note: EBV negative patients can be included if the donor is confirmed EBV negative)
- Malignant disease within 2 years prior to Screening, except basal cell carcinomas of the skin and in situ carcinomas
- Immunosuppressive therapy (e.g., for the treatment of an auto-immune disease) within 6 months prior Screening
- Preexisting vasculitis or collagenosis
- Known presence of irregular antibodies in Coombs test
- Vaccination within 4 weeks prior to Screening
- Spleen removed
- Known or suspected abuse of alcohol, drugs, or medicinal products
- Pregnant or breastfeeding
- Female patients who have a child with the donor or were pregnant from the donor due to possible sensitization
- Known history of hypersensitivity to the cellular components or to any other constituent/excipient in the pharmaceutical formulation of MIC (e.g., components of the SSP+ buffer as electrolytes (sodium chloride...
- Any finding or medical condition prohibiting the inclusion in the trial according to the judgment of the investigator
- Participation in an treatment clinical trial within 30 days prior to Screening or in observation period of a competing study
- Employees of the sponsor, or employees or relatives of the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Hamburg, Germany
- Heidelberg, Germany
- Munich, Germany
- Münster, Germany
- Stuttgart, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Hamburg, Germany; Heidelberg, Germany; Munich, Germany; Münster, Germany; Stuttgart, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.