Steroid Withdrawal and Donor-specific Anti-HLA Antibodies in Renal Transplant Patients

Inclusion criteria

• Male and female patients aged over 18 years with no immunological risk (PRA <25% and no DSA) who are receiving their first cadaveric or living kidney transplant.
• Patients who, three months after the transplantation, are receiving tacrolimus in combination with mycophenolic acid (MPA) or mycophenolate mofetil (MMF) plus steroids, with stable plasma levels of tacrolimus.
• No clinical or histological immunological dysfunction before randomization
• No de novo anti-HLA DSA at the time of randomization.
• Patients who wish to and are able to give written informed consent to participate in the study.
• For women, agreeing to use efficient contraception during the study.

Exclusion criteria

• Patients who receive a multiorgan transplant.
• Retransplants.
• Presence of DSA before the transplant or at the time of randomization.
• Cold ischemia time >30 hours
• Patients with serum creatinine >2 mg/dL or proteinuria >1g/day at the time of randomization
• Prior episode of severe rejection (II-B-III in the Banff/13 classification) prior to randomization.
• Presence of subclinical rejection on the protocol biopsy prior to randomization
• Patients with BK-polyomavirus nephropathy at the time of randomization.
• Patients with recurrent or de novo glomerulonephritis.
• Patients who are being treated with immunosuppressive drugs other than those in the randomized clinical trial in question.
• Patients who are positive for the human immunodeficiency virus (HIV) or those who have a severe systemic infection that, in the investigator's judgment, will require continued treatment.
• Patients with any present or prior (during the previous 5 years) malignant disease, except basal or squamous cell carcinoma that has been excised.