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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney transplanted patients treated with Nulojix | Patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belatacept Injection [Nulojix] | Drug | Drugs administrated are part of the usual care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute rejection occurence | Occurence of cellular rejection according to the BANFF 2017 | 1 year or rejection |
| Measure | Description | Time Frame |
|---|---|---|
| Gut and circulating microbiota | 16S DNA sequencing | 1 year or rejection |
| Lymphocyte phenotype | CD3+CD4+CD57+PD1-, CD3+CD8+CD28low, CD3+CD8+CD45RA phenotype |
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Inclusion Criteria:
Exclusion Criteria:
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70 patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine Durrbach, MD-PhD | Contact | +33614112981 | antoine.durrbach@inserm.fr | |
| florence Herr, PhD | Contact | +33663680985 | florence.herr@inserm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine Durrbach, MD-PhD | Institut National de la Santé Et de la Recherche Médicale, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrologie transplantation CHRU Besançon | Recruiting | Besançon | 25000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20634298 | Background | Vincenti F, Blancho G, Durrbach A, Friend P, Grinyo J, Halloran PF, Klempnauer J, Lang P, Larsen CP, Muhlbacher F, Nashan B, Soulillou JP, Vanrenterghem Y, Wekerle T, Agarwal M, Gujrathi S, Shen J, Shi R, Townsend R, Charpentier B. Five-year safety and efficacy of belatacept in renal transplantation. J Am Soc Nephrol. 2010 Sep;21(9):1587-96. doi: 10.1681/ASN.2009111109. Epub 2010 Jul 15. | |
| 20415898 |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| D000077552 | Basiliximab |
| D009173 | Mycophenolic Acid |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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Blood Stool
| 1 year or rejection |
| Glomerular filtration rate | CDK-EPI creatinine equation | 1 year or rejection |
| Néphrologie, hémodialyse, aphérèses, transplantation rénale | Recruiting | La Tronche | 38700 | France |
|
| Nephrologie transplantation CHRU Nantes | Recruiting | Nantes | 44200 | France |
|
| Nephrologie transplantation CHU Saint Louis Paris | Recruiting | Paris | 75010 | France |
|
| Nephrologie transplantation CHU Pitié Salpetriere Paris | Recruiting | Paris | 75013 | France |
|
| Nephrologie hôpital Henri-Mondor | Recruiting | Paris | 94010 Créteil | France |
|
| Nephrologie transplantation CHRU Poitiers | Recruiting | Poitiers | 86021 | France |
|
| Nephrologie transplantation CHRU Toulouse | Recruiting | Toulouse | 31059 Toulouse Cedex 9 | France |
|
| Nephrologie transplantation CHRU Tours | Recruiting | Tours | 37044 | France |
|
| Background |
| Durrbach A, Pestana JM, Pearson T, Vincenti F, Garcia VD, Campistol J, Rial Mdel C, Florman S, Block A, Di Russo G, Xing J, Garg P, Grinyo J. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant. 2010 Mar;10(3):547-57. doi: 10.1111/j.1600-6143.2010.03016.x. |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D007162 | Immunoproteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |