ANTI-T LYMPHOCYTE IMMUNOGLOBULIN FOR HUMAN USE, RABBIT for Kidney transplant | Borderline T-cell rejection (early, kidney transplant)

Inclusion criteria

• {"criterion_text":"- Patients of both sexes, over 18 years of age without immunological risk (PRA <20% and absence of DSA), who receive a first kidney graft from a deceased donor or a living donor.\n- b) Presence of BL injuries, which will be defined according to the Banff 2019 classification as the presence of a interstitial inflammation score (i) and tubulitis score (t) of at least 1 point (t>0; i>0), but without reaching the threshold determined for 1A rejection of the Banff'19 classification (i2,t2) and without transmural arteritis (v0), excluding isolated inflammation (t0, i>0) and isolated tubulitis (t>0, i0).\n- c) Patients who are receiving Tacrolimus in combination with mycophenolic acid (MPA) and steroids;\n- d) Absence of clinical or subclinical and histological immunological dysfunction before randomization;\n- e) Absence of anti-HLA de novo DSA antibodies at the time of randomization;\n- f) Patients who wish and who Clinical trial protocol 6 can give written informed consent to participate in the study;\n- g) Acceptance of efficient contraception recommended by the Clinical Trial Facilitation Group in women of childbearing age during the study."}

Exclusion criteria

• {"criterion_text":"- a)Patients receiving a multi-organ transplant;\n- b) Retransplants;\n- c) Patients without inflammation in the protocol biopsy of the third month (i0, t0), isolated inflammation without tubulitis (t0, i>0) or isolated tubulitis no inflammation (t>0, i0);\n- d) Cold ischemia time >30 hours;\n- e) Patients with higher serum creatinine at 2 mg/dl or proteinuria greater than 1g/day at the time of randomization;\n- f) Presence of significant plateletopenia (<100,000/mm3) or leukopenia (<3,000/mm3) at the time of randomization;\n- g) Previous clinical or subclinical rejection episode (≥AI) of the Banff classification 19 before randomization;\n- h) Presence of borderline lesions detected in a biopsy requested by clinical indication prior to the 3rd month protocol biopsy;\n- i) Patients with infection or CMV disease in the first three months of transplant;\n- j) Patients with BKpoliomavirus nephropathy at the time of randomization:\n- k) Patients with recurrent glomerulonephritis or new;\n- l) Patients who are being treated with immunosuppressive drugs other than those in the trial clinician in question;\n- m) Patients who are positive for the human immunodeficiency virus (HIV) or with severe systemic infection, which in the opinion of the investigator requires continued therapy;\n- n) Patients with any previous (during the last 5 years) or present malignant disease, except carcinoma basal or squamous cell excised;\n- ñ) Pregnant or breastfeeding women."}

Primary endpoints

• {"endpoint_text":"- Presence of Interstitial Fibrosis and Tubular Atrophy (FIAT) and calculated renal function of the graft with CKD-EPI at 24 months of the study in both therapeutic arms.","definition_or_measurement_approach":"Presence of FIAT assessed histologically (Banff criteria) and graft renal function calculated using the CKD-EPI equation at 24 months."}

Secondary endpoints

• {"endpoint_text":"- Patient and graft survival.\n-  Rate of clinical and biopsy-confirmed acute rejection, and proteinuria at 3, 6, 12 and 24 months.\n-  Blood pressure figures and number of hypotensive agents, lipid levels and need for lipid-lowering, and weight and BMI increase.\n-  Rate of post-transplant diabetes (PTDM) or glucose intolerance at one year and the second year of transplantation according to ADA criteria.\n-  Adherence to immunosuppressive treatment evaluated using the Basel scale.","definition_or_measurement_approach":"Survival via clinical follow-up; acute rejection by clinical criteria and biopsy confirmation; proteinuria measured at specified timepoints; blood pressure measurements and medication counts; lipid levels and need for lipid-lowering therapy; weight and BMI changes; PTDM/glucose intolerance per ADA criteria at year 1 and year 2; adherence measured with the Basel scale."}

Spain

Earliest CTIS Part Ii Submission Date

22-01-2025

Latest Decision Or Authorization Date

29-01-2025

Processing Time Days

7

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Fundacion Canaria Instituto De Investigacion Sanitaria De Canarias

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain