NCT04736381

Impact of the Microbiota on the Likelihood of Renal Graft Rejection

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Kidney Transplant Rejection

Interventions

Type	Name	Description
DRUG	Belatacept Injection [Nulojix]	Drugs administrated are part of the usual care

Timeline

• Start date: 2021-10-07
• Primary completion: 2027-01-07
• Completion: 2027-01-07
• First posted: 2021-02-03
• Last updated: 2025-04-10

Locations

9 sites across 1 country: France

Regulatory

• FDA-regulated drug study