METHYLPREDNISOLONE for Kidney transplant

Inclusion criteria

• {"criterion_text":"- Adult men and women (≥ 18 years)\n- Recipients of a first kidney transplant from a living donor who is HLA-incompatible (at least 1 HLA mismatch at any antigen level).\n- AB0 compatible transplant\n- 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).\n- Patients who agree to participate in the trial by signing the Informed Consent specific to this study.\n- 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.\n- 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.\n- 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."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Patients with any neoplasia except localized skin cancer and who are receiving appropriate treatment.\n- Patients with severe anemia (hemoglobin <6 g/dl), leukopenia (WBC <2500/mm3) and/or thrombocytopenia (platelets <80,000/mm3).\n- Hemodynamically unstable patients even if they have hemoglobin levels >6 g/dl.\n- Patients with intestinal pathology or severe diarrhea that may decrease absorption according to medical criteria.\n- Patients with known hypersensitivity to any of the drugs used in this study.\n- Patients who have received any investigational drug in the 30 days prior to inclusion in this study.\n- 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.\n- Patients who are legally detained in an official institution.\n- Positive Cross Match result\n- Patients who receive a graft from a cadaver donor.\n- HLA-identical patients\n- Patients who have undergone a previous solid organ transplant (including kidney transplant) or who will receive another concomitant solid organ transplant.\n- Patients with any of the following underlying renal diseases: a. Primary focal segmental glomerular sclerosis b. Atypical Hemolytic Urémic Syndrome (aHUS) / Thrombotic Thrombocytopenic Purpura Syndrome.\n- Patients with active Hepatitis B virus (HBV) infection and/or active Hepatitis C virus infection (positive PCR result) at the time of transplant.\n- Patients with known Human Immunodeficiency Virus (HIV) infection.\n- Patients with active systemic infection requiring continued administration of antibiotics."}

Primary endpoints

• {"endpoint_text":"- Composite variable evaluated at 2 years of follow-up as a proportion of patients meeting any of the following criteria: loss of renal function, incidence of biopsy-confirmed clinical acute rejection (BPAR), and development of dnDSA.","definition_or_measurement_approach":"Composite variable evaluated at 2 years of follow-up as a proportion of patients meeting any of the following criteria: loss of renal function, incidence of biopsy-confirmed clinical acute rejection (BPAR), and development of dnDSA."}

Secondary endpoints

• {"endpoint_text":"- Mortality from any cause at 24 months\n- Kidney graft loss at 24 months\n- Incidence and severity of subclinical and chronic rejection (according to protocol biopsies at 3 and 24 months)\n- Incidence of opportunistic infections at 24 months\n- Incidence of treatment-related metabolic disorders (diabetes mellitus, dyslipidemia, and hypertension) at 24 months f- Incidence of cardiovascular events at 24 months\n- Incidence of malignancy (cutaneous and noncutaneous cancer) at 24 months\n- Proportion of patients maintaining treatment according to protocol at the end of the trial\n- Changes in immune response at 24 months according to biomarkers: - allogeneic response (dn-DSA, ELISPOT IFN-γ d-sp, Memory B cell Elispot, urine cytokines CXCL9 and CXCL10) - transcriptional profile in blood of rejection risk according to the kSORT test - antiviral cellular response against CMV, EBV, VBK viruses; NKG2\n- Study of economic cost and study of adherence to treatment (using mobile Health application).\n- Serious adverse reactions (serious adverse events with a possible causal relationship with immunosuppressive treatment).","definition_or_measurement_approach":"Endpoints measured at specified timepoints (primarily 24 months and protocol biopsies at 3 and 24 months). Specific measurement approaches include mortality assessment, graft loss assessment, biopsy-confirmed rejection (protocol biopsies), incidence counts of infections, metabolic disorders and malignancy at 24 months, immunological biomarker assays (dn-DSA, ELISPOT IFN-γ d-sp, Memory B cell Elispot, urine CXCL9/CXCL10), kSORT transcriptional profile, antiviral cellular response assays, economic cost analysis and adherence measured using a mobile Health application; serious adverse reactions assessed as SAEs with possible causal relationship to immunosuppressive treatment."}

Spain

Earliest CTIS Part Ii Submission Date

28-01-2025

Latest Decision Or Authorization Date

30-01-2025

Processing Time Days

2

Number Of Sites

6

Number Of Participants

164

Primary sponsor

Full Name

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain