Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity.

Non randomized, pilot, prospective, open-label trial.

Inclusion criteria

• Age of donor and recipient between 18 and 65 years.
• End-stage renal disease and scheduled to receive a primary or secondary renal allograft from a cadaveric, a living-unrelated, or a living-related donor. Patients scheduled for a second transplant must have maintained their primary graft for at least 6 months after transplantation, with the exception of graft failure due to technical reasons.
• Panel reactive antibody (PRA) ≤ 20%, with negative standard cross-match.
• Women of childbearing potential must have a negative serum pregnancy test before randomization.
• Women of childbearing potential must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.
• Signed and dated informed consent prior to transplantation.

Exclusion criteria

• Multiple organ transplants
• Recipients of adult or pediatric en bloc kidney transplants or dual transplantation or non-heart beating donors.
• Evidence of active systemic or localized major infection.
• Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during the screening/baseline evaluation.
• Use of any investigational drug or treatment up to 4 weeks prior to transplantation.
• Treatment with voriconazole, ketoconazole, itraconazole, fluconazole, clotrimazole, astemizole, pimozide, terfenadine, erythromycin, clarithromycin, telithromycin, troleandomycin, rifampin, rifabutin, or St. John's Wort that is not discontinued prior to randomization.
• Treatment with aminoglycosides, amphotericin B, cisplatin, cisapride, metoclopramide, cimetidine, bromocriptine, danazol, or other drugs associated with renal dysfunction that are not discontinued prior to randomization.
• Subjects with a screening/baseline total white blood cell count < 2,000/mm3 or absolute neutrophil count (ANC) < 500, platelet count < 100,000/mm3.
• Fasting triglycerides > 400 mg/dL (> 4.6 mmol/L) or fasting total cholesterol > 300 mg/dL (> 7.8 mmol/L) despite optimal lipid-lowering therapy.
• History of malignancy within 2 years of enrollment (except for adequately treated basal cell or squamous cell carcinoma of the skin).
• Auto-immune diseases inactive immunosuppressive treatment ( 3 months prior to inclusion).
• Patient with psychiatric disorders that could be non-compliance for the treatment.
• Non Caucasian patients.
• Active peptic ulcers that could produce intestinal absorption disorders.
• Subjects who are known to be human immunodeficiency virus(HIV) or hepatitis B virus (HBV) positive. Patients with hepatitis C virus (HCV) positive should be excluded if polymerase chain reaction (PCR) positive or transaminates values are ≥2 upper normal value (UNV).
• Diabetic patients.
• Body mass index higher than 30 Kg/m2.