Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME) (CIME)

This is an interventional treatment trial for Kidney Failure focused on measuring kidney, transplantation, graft, creatinin Read More

Inclusion Criteria:

• Males and Females aged between 18 and 70.
• Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated.
• Patient with a maximum PRA <20%.
• Patient wishing and being able to participate fully to the study, and having given a written consent.
• Patient covered by a social insurance or beneficiary of such a regime.
• Women of childbearing age must use a recognized method of contraception throughout the study period and continue for 8 weeks after discontinuation of study treatment.

Exclusion Criteria:

• Patient receiving a kidney from a heart attack donor , or an ABO incompatible donor or a donor with a positive T-cross match.
• Patient with a maximum PRA> 20% twice.
• Cold ischemic time > 36 hours.
• Patients with thrombocytopenia (<75000/mm3), neutropenia (<1 500 / mm3), leukopenia (<2 500 / mm3) or a hemoglobin concentration <8 g / dl, at inclusion visit.
• Patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol / l (≥ 3.50 g / l) and / or triglycerides ≥ 8.5 mmol/l (≥ 7.5 g / l) despite appropriate lipid-lowering therapy.
• Patient with known HIV positive status, know active hepatitis B or C. Recipients of an organ from a donor with positive HIV status, hepatitis B or hepatitis C are excluded.
• Patient with severe systemic infections requiring continued therapy.
• Treatment with an experimental drug within 4 weeks before the first dose of study treatment.
• Patient for whom the initial disease or other pathology requires a long-term corticosteroid treatment.
• Patient with a history of hypersensitivity or known contra-indications for macrolide or inhibitors of mTORs drugs; drugs similar to Myfortic ® (ERL080) or other components of the formulation such as lactose, or cyclosporine, or prednisone (Cortancyl ®), or Thymoglobuline ® or Iohexol.
• Patient with a malignant disease or a history of malignancy over the past 5 years except squamous-cell or basal cell carcinoma wich was excised.
• Medical condition or surgical procedure, except transplantation, which could exclude the patient in the opinion of the investigator.
• Patient with symptoms of mental or significant somatic illness. Disability to cooperate or communicate with the investigator.
• Pregnant, sucking or of childbearing age and refusing or being unable to use a recognized contraceptive method.
• Patient under guardianship, or any patient protected by law.