RecruitingNCT04736381

Impact of the Microbiota on the Likelihood of Renal Graft Rejection


Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrollment

70 participants

Start Date

Oct 7, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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

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Interventions

DRUGBelatacept Injection [Nulojix]

Drugs administrated are part of the usual care


Locations(9)

Nephrologie transplantation CHRU Besançon

Besançon, France

Néphrologie, hémodialyse, aphérèses, transplantation rénale

La Tronche, France

Nephrologie transplantation CHRU Nantes

Nantes, France

Nephrologie transplantation CHU Saint Louis Paris

Paris, France

Nephrologie transplantation CHU Pitié Salpetriere Paris

Paris, France

Nephrologie hôpital Henri-Mondor

Paris, France

Nephrologie transplantation CHRU Poitiers

Poitiers, France

Nephrologie transplantation CHRU Toulouse

Toulouse, France

Nephrologie transplantation CHRU Tours

Tours, France

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NCT04736381


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