Absence of Steroid in Renal Transplantation and Digital Fibrosis Observation

Pre-Inclusion Criteria:

• Adults aged 18 to70 years,
• Accepting to give, after information, their signed informed consent form,
• Not having difficulties to understand and communicate with the investigator and his representatives,
• Requiring a renal transplant [first or second transplant (except if the first renal transplant was lost due to rejection)],
• Patient insured.

Inclusion criteria

• Transplant of a kidney from a deceased or living donor (non HLA-identical) with ABO compatibility,
• Existence of a renal graft biopsy (or of one of the grafts, if bi-renal transplant) before transplantation,
• Percentage of positive responses to PRA (panel reactive antibodies), measured by the Luminex® less than 20% of IgG anti-T or absence of positive DSA by Luminex regardless of the mean fluorescence (MFI) within the last 6 months,
• Negative cross match T in cytotoxicity and / or flow cytometry,
• Negative pregnancy test for patients of childbearing age, and consent to use an effective contraception throughout the study and 6 weeks after the end of the study.

Exclusion criteria

• First renal transplant lost due to rejection,
• Combined transplantation,
• Previous history of transplantation other than kidney,
• Non beating donor heart,
• Presence of positive DSA by Luminex® regardless of the average of fluorescence (MFI),
• Patients receiving corticosteroids at the time of transplantation,
• Necessity to continue administration of systemic immunosuppressive treatment before transplantation,
• Infections or severe diarrhea, vomiting, upper gastrointestinal tract malabsorption or active peptic ulcers, concomitant, significant and uncontrolled,
• Subject or HIV positive donor,
• Replicating viral hepatitis at the time of randomization,
• Known allergy or intolerance to tacrolimus, macrolide, corticosteroids, mycophenolate mofetil or to any of the excipients,
• Diagnosis of de novo malignancy prior to transplantation, with the exception of treated effectively basal cell or squamous cell carcinomas of the skin,- Current participation at another clinical study,
• All clinical condition that the investigator considers incompatible with the conduct of the study in acceptable security conditions,
• Inability of patient to comply with study procedures,
• Pregnant or breast-feeding women,
• Person placed under guardianship, under protection of law.