Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING)

Inclusion Criteria:

• Patients of either sex, older than 18 years, with no immunological risk (PRA<20% andabsence of DSA), who receive their first deceased donor or living donor KT.
• Presence of BL, excluding isolated inflammation (t0, i>0) and isolated tubulitis (t>0,i0).
• Patients receiving tacrolimus in combination with mycophenolic acid (MPA) andsteroids.
• Absence of clinical or subclinical and histological immunological dysfunction beforerandomization.
• Absence of de novo DSA anti-HLA antibodies at the time of randomization.
• Provision of written informed consent.
• Acceptance of efficient contraception in women.

Exclusion Criteria:

• Recipients of a multi-organ transplant.
• Re-transplants.
• Patients without inflammation in the third month protocol biopsy (i0,t0), or withisolated inflammation without tubulitis (t0,i>0) or isolated tubulitis withoutinflammation (t>0,i0).
• Presence of DSA antibodies before transplantation or at randomization.
• Cold ischemia time >30 hours.
• Serum creatinine >2.5 mg/dl or proteinuria >1 g/day at randomization.
• Presence of significant thrombopenia (<100,000/mm3) or leukopenia (<3000 mm/3) atrandomization.
• Previous episode of clinical or subclinical rejection (≥IA) before randomization.
• CMV disease in the first three months after transplantation.
• BK-polyomavirus nephropathy at randomization.
• Recurrent or de novo glomerulonephritis.
• Treatment with immunosuppressive drugs other than those in this clinical trial.
• Patients who are positive for the human immunodeficiency virus (HIV) or with severesystemic infection, who, in the opinion of the investigator, require continuedtherapy.
• Previous (within the last 5 years) or present malignancy, except excised basal orsquamous cell carcinoma.