Ignite Creation Date:
2024-05-06 @ 8:52 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02843841
Status:
UNKNOWN
Last Update Posted:
2017-01-31
First Post:
2016-07-19
Brief Title:
Polyclonal Antilymphocyte Globulin ATG Intestinal Immune Barrier After Kidney Transplantation
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Polyclonal Antilymphocyte Globulin ATG Intestinal Immune Barrier After Kidney Transplantation
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GABII
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None