Kidney Transplant Rejection
Conditions
Keywords
Microbiota, Belatacept, Second signal inhibitor
Brief summary
Identification of a bacterial signature in the blood or stool that may be associated with acute rejection in patients treated with Nulojix during their first year of transplant.
Detailed description
Gut microbiota as well as the signature of the 16S plasma bacterial DNA and bacterial metabolites of patients on the date of transplantation and during the first year after transplantation will be analyzed. The phenotype of the patients' T lymphocytes will be analyzed at the same time. These data will be correlated with the occurrence of acute cell rejection during the first year of transplantation
Interventions
DRUGBelatacept Injection [Nulojix]
Drugs administrated are part of the usual care
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients called for a kidney transplant * Induction therapy with Simulect, maintenance therapy with Nulojix, mycophenolate acid and steroids * Patient having signed the informed consent
Exclusion criteria
* Multiple grafts combined or sequential * Induction therapy with polyclonal antibodies * HIV or active viral infection such as hepatitis B or C * Active bacterial infection * Pregnancy or breastfeeding at time of inclusion * Patient unable to express their consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute rejection occurence | 1 year or rejection | Occurence of cellular rejection according to the BANFF 2017 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut and circulating microbiota | 1 year or rejection | 16S DNA sequencing |
| Lymphocyte phenotype | 1 year or rejection | CD3+CD4+CD57+PD1-, CD3+CD8+CD28low, CD3+CD8+CD45RA phenotype |
| Glomerular filtration rate | 1 year or rejection | CDK-EPI creatinine equation |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAntoine Durrbach, MD-PhD
Institut National de la Santé Et de la Recherche Médicale, France
Outcome results
None listed