BridgeMD
MULTICENTER, RANDOMIZED STUDY TO EVALUATE THE EFFICACY OF INDIVIDUALIZATION OF IMMUNOLOGICAL RISK BASED ON SELECTIVE BIOMARKERS (HLA EPLETH DISPARITY AND IFN-γ ELISPOT) TO OPTIMIZE IMMUNOSUPPRESSIVE TREATMENT IN LIVING DONOR KIDNEY TRANSPLANT PATIENTS (BIOIMMUN)
EU CTIS ID: 2025-520884-42-00
What this study is testing
To determine the effect of individualizing immunosuppressive therapy based on baseline immunologic risk stratification according to 2 biomarkers (ELISPOT IFN-γ d-sp and HLA-enhanced mismatch), on a composite endpoint of loss of renal function, incidence of biopsy-confirmed clinical acute rejection (BPAR), and development of dnDSA at 2 years of follow-up in patients receiving kidney transplants from living donors compared with patients followed according to a standard, non-individualized immunosuppressive regimen.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult men and women (≥ 18 years)
- Recipients of a first kidney transplant from a living donor who is HLA-incompatible (at least 1 HLA mismatch at any antigen level).
- AB0 compatible transplant
- Patients with a calculated PRA <= 75% by solid phase technique and absence of current or historical class I and class II donor-specific anti-HLA antibodies (DSA).
- Patients who agree to participate in the trial by signing the Informed Consent specific to this study.
- Females of Childbearing Potential must use highly reliable methods of contraception (Pearl-Index < 1) to prevent pregnancy throughout the duration of the study and for 6 weeks following completion of treatment with Mycophenolate Mofetil (MMF). Females of Childbearing Potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months, or women who are receiving hormone replacement therapy with a documented follicular-stimulating hormone (FSH) level > 35 mlU/ml). Women of Childbearing Potential must have a negative pregnancy test performed within 72 hours prior to the start of the trial.
You likely can't join if
- Patients with a calculated PRA >75% by solid phase technique and/or the presence of current or historical donor-specific anti-HLA antibodies (DSA) of class I and class II.
- Patients with any neoplasia except localized skin cancer and who are receiving appropriate treatment.
- Patients with severe anemia (hemoglobin <6 g/dl), leukopenia (WBC <2500/mm3) and/or thrombocytopenia (platelets <80,000/mm3).
- Hemodynamically unstable patients even if they have hemoglobin levels >6 g/dl.
- Patients with intestinal pathology or severe diarrhea that may decrease absorption according to medical criteria.
- Patients with known hypersensitivity to any of the drugs used in this study.
See the full eligibility criteria
Who can join
- Adult men and women (≥ 18 years)
- Recipients of a first kidney transplant from a living donor who is HLA-incompatible (at least 1 HLA mismatch at any antigen level).
- AB0 compatible transplant
- Patients with a calculated PRA <= 75% by solid phase technique and absence of current or historical class I and class II donor-specific anti-HLA antibodies (DSA).
- Patients who agree to participate in the trial by signing the Informed Consent specific to this study.
- Females of Childbearing Potential must use highly reliable methods of contraception (Pearl-Index < 1) to prevent pregnancy throughout the duration of the study and for 6 weeks following completion of treatment with Mycophenolate Mofetil (MMF). Females of Childbearing Potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months, or women who are receiving hormone replacement therapy with a documented follicular-stimulating hormone (FSH) level > 35 mlU/ml). Women of Childbearing Potential must have a negative pregnancy test performed within 72 hours prior to the start of the trial.
- Sexually active men (including vasectomized men) receiving MMF therapy must agree to use barrier methods of contraception during treatment with MMF and for 90 days thereafter. Partners of childbearing potential of these patients should use a reliable method of contraception during the same period to minimize the risk of pregnancy.
- Patients must agree not to donate blood during treatment with MMF and for 6 weeks afterward. Men must not donate sperm during treatment with MMF and for 90 days after completion of treatment.
What rules you out
- Patients with a calculated PRA >75% by solid phase technique and/or the presence of current or historical donor-specific anti-HLA antibodies (DSA) of class I and class II.
- Patients with any neoplasia except localized skin cancer and who are receiving appropriate treatment.
- Patients with severe anemia (hemoglobin <6 g/dl), leukopenia (WBC <2500/mm3) and/or thrombocytopenia (platelets <80,000/mm3).
- Hemodynamically unstable patients even if they have hemoglobin levels >6 g/dl.
- Patients with intestinal pathology or severe diarrhea that may decrease absorption according to medical criteria.
- Patients with known hypersensitivity to any of the drugs used in this study.
- Patients who have received any investigational drug in the 30 days prior to inclusion in this study.
- Potentially Childbearing Women who do not agree to use reliable contraceptive measures during the trial, who are pregnant, breastfeeding, or who have a positive pregnancy test at the time of inclusion in the study.
- Patients who are legally detained in an official institution.
- Positive Cross Match result
- Patients who receive a graft from a cadaver donor.
- HLA-identical patients
- Patients who have undergone a previous solid organ transplant (including kidney transplant) or who will receive another concomitant solid organ transplant.
- Patients with any of the following underlying renal diseases: a. Primary focal segmental glomerular sclerosis b. Atypical Hemolytic Uremic Syndrome (aHUS) / Thrombotic Thrombocytopenic Purpura Syndrome.
- Patients with active Hepatitis B virus (HBV) infection and/or active Hepatitis C virus infection (positive PCR result) at the time of transplant.
- Patients with known Human Immunodeficiency Virus (HIV) infection.
- Patients with active systemic infection requiring continued administration of antibiotics.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.