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)
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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