Disorder Related to Renal Transplantation Clinical Trial
Official title:
Polyclonal Antilymphocyte Globulin (ATG) & Intestinal Immune Barrier After Kidney Transplantation
The prevention of allograft rejection in kidney transplantation requires administering to
the patient an immunosuppressive regimen of induction. The induction strategy is based on an
injection of polyclonal anti-lymphocyte globulin (ATG-FLAG or fresenius®) driving a
lymphocyte lysis, or an injection of monoclonal antibodies directed against non-lymphopenic
the α chain of the IL-receptor 2 (anti-CD25 antibody, basiliximab), by immunological risk
patients. Our group showed a significant increase in death rates in transplant patients with
lymphopenia CD4 continued beyond 2 years of transplantation. This excess mortality is
related to complications following chronic inflammation observed in some patients
lymphopenic.
Preliminary studies have shown that the induced lymphodéplétion ATG appears to be
accompanied by an increase of the bacterial products in the blood of transplanted since a
significant increase in the sCD14 is observed in these patients one year. We also observed
increased concentrations of LPS in patients in the ATG group. This could indicate a
secondary bacterial intestinal translocation to a weakening of intestinal immunity linked to
the ATG.
The main objective of the study is to assess the impact of anti-lymphocyte globulin
polyclonal on intestinal permeability, estimated by the rate lipopolysaccharide (LPS, a
constituent of the cell wall of Gram-negative bacteria) blood after kidney transplantation.
The secondary objectives are to evaluate bacterial translocation, the effect of bacterial
translocation on structural and metabolic functions of the intestinal epithelium, chronic
inflammation, immune reconstitution, regeneration, activation and proliferation of T
lymphocytes, the polymorphism of the LPS receptor that causes the activation of innate
immunity and the composition of the intestinal microbiota.
The study population consists of renal transplant patients of Nephrology of the University
Hospital of Besancon. Patients will be divided into 2 groups according to induction
immunosuppressive therapy prescribed the day of renal transplantation as part of their usual
care, ie treatment with anti-lymphocyte globulin polyclonal (ATG-Fresenius®) or antibody
treatment monoclonal anti-CD25 (basiliximab Simulect). The patient group treated with
anti-CD25 antibody will serve as a control group (no depletion of the immune system) to the
group of patients treated with ATG.
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