Impact of the Microbiota on the Likelihood of Renal Graft Rejection

Recruiting

• Conditions: Kidney Transplant Rejection
• Interventions: Drug: Belatacept Injection [Nulojix]

• Registration Number: NCT04736381
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Study Start: 2021-10-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2027-01-07
• Study Completion: 2027-01-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney transplanted patients treated with Nulojix	Belatacept Injection [Nulojix]	Patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant.

Primary Outcome Measures

Name	Time	Method
Acute rejection occurence	1 year or rejection	Occurence of cellular rejection according to the BANFF 2017

Secondary Outcome Measures

Name	Time	Method
Lymphocyte phenotype	1 year or rejection	CD3+CD4+CD57+PD1-, CD3+CD8+CD28low, CD3+CD8+CD45RA phenotype
Gut and circulating microbiota	1 year or rejection	16S DNA sequencing
Glomerular filtration rate	1 year or rejection	CDK-EPI creatinine equation

Trial Locations

Locations (9)

Nephrologie transplantation CHRU Besançon; 🇫🇷 Besançon, France

Néphrologie, hémodialyse, aphérèses, transplantation rénale; 🇫🇷 La Tronche, France

Nephrologie transplantation CHRU Nantes; 🇫🇷 Nantes, France

Nephrologie transplantation CHRU Poitiers; 🇫🇷 Poitiers, France

Nephrologie transplantation CHU Saint Louis Paris; 🇫🇷 Paris, France

Nephrologie hôpital Henri-Mondor; 🇫🇷 Paris, France

Nephrologie transplantation CHRU Toulouse; 🇫🇷 Toulouse, France

Nephrologie transplantation CHU Pitié Salpetriere Paris; 🇫🇷 Paris, France

Nephrologie transplantation CHRU Tours; 🇫🇷 Tours, France