Clinical trial NCT04736381: Impact of the Microbiota on the Likelihood of Renal Graft Rejection
Official title: Impact of the Microbiota on the Likelihood of Renal Graft Rejection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant Rejection
Keywords: Microbiota
Belatacept
Second signal inhibitor
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2021-02-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 70 patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant.

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

Eligibility criteria: 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

Primary outcomes:
measure: Acute rejection occurence
timeFrame: 1 year or rejection
Secondary outcomes:
measure: Gut and circulating microbiota
timeFrame: 1 year or rejection
measure: Lymphocyte phenotype
timeFrame: 1 year or rejection
measure: Glomerular filtration rate
timeFrame: 1 year or rejection
Other outcomes:
Locations:
city: Besançon
country: France
facility: Nephrologie transplantation CHRU Besançon
city: La Tronche
country: France
facility: Néphrologie, hémodialyse, aphérèses, transplantation rénale
city: Nantes
country: France
facility: Nephrologie transplantation CHRU Nantes
city: Paris
country: France
facility: Nephrologie transplantation CHU Saint Louis Paris
city: Paris
country: France
facility: Nephrologie transplantation CHU Pitié Salpetriere Paris
city: Paris
country: France
facility: Nephrologie hôpital Henri-Mondor
city: Poitiers
country: France
facility: Nephrologie transplantation CHRU Poitiers
city: Toulouse
country: France
facility: Nephrologie transplantation CHRU Toulouse
city: Tours
country: France
facility: Nephrologie transplantation CHRU Tours
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Antoine Durrbach, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.