Status:

RECRUITING

Impact of the Microbiota on the Likelihood of Renal Graft Rejection

Lead Sponsor:

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

Conditions:

Kidney Transplant Rejection

Eligibility:

All Genders

18-70 years

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 ana...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 7 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 7 2027

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT04736381

Start Date

October 7 2021

End Date

January 7 2027

Last Update

April 10 2025

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

Nephrologie transplantation CHRU Besançon

Besançon, France, 25000

2

Néphrologie, hémodialyse, aphérèses, transplantation rénale

La Tronche, France, 38700

3

Nephrologie transplantation CHRU Nantes

Nantes, France, 44200

4

Nephrologie transplantation CHU Saint Louis Paris

Paris, France, 75010