Five-year safety and efficacy of belatacept in renal transplantation.
Flavio Vincenti, Gilles Blancho, Antoine Durrbach...
https://pubmed.ncbi.nlm.nih.gov/20634298Actively Recruiting
Age: 18Years - 70Years
All Genders
ID04736381
Impact of the Microbiota on the Likelihood of Renal Graft Rejection
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2025-04-10
70
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how the gut microbiota and bacterial DNA signatures in the blood or stool may be linked to acute rejection in patients who have received a kidney transplant and are treated with Nulojix. The study focuses on patients during the first year after transplantation to better understand factors that could influence transplant rejection. Participants receive standard care that includes induction therapy with Simulect and maintenance therapy with Nulojix, mycophenolic acid, and steroids throughout the first year following their kidney transplant. The study closely monitors these patients to analyze their gut and blood bacterial profiles and immune cell characteristics. Throughout the study, patients will have their gut and circulating microbiota analyzed along with the phenotype of their T lymphocytes. Researchers will correlate these data with rates of acute rejection and measure kidney function using glomerular filtration rate. The study follows participants for one year or until rejection occurs to assess these outcomes under regular monitoring.
CONDITIONS
Brief Title
Impact of the Microbiota on the Likelihood of Renal Graft Rejection
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients called for a kidney transplant
- Induction therapy with Simulect and maintenance therapy with Nulojix, mycophenolate acid, and steroids
- Patient having signed the informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 1 year or until rejection
Participants who undergo routine kidney transplant care with immunosuppressive drugs are observed. Gut microbiota, bacterial DNA, bacterial metabolites, and lymphocyte phenotypes are analyzed from the date of transplantation and during the first year afterward.
Regular assessments during the first year after transplantation
Trial Site Locations
Total: 9 locations
1
Nephrologie transplantation CHRU Besançon
Besançon, France, 25000
Actively Recruiting
2
Néphrologie, hémodialyse, aphérèses, transplantation rénale
La Tronche, France, 38700
Actively Recruiting
3
Nephrologie transplantation CHRU Nantes
Nantes, France, 44200
Actively Recruiting
4
Nephrologie transplantation CHU Saint Louis Paris
Paris, France, 75010
Actively Recruiting
5
Nephrologie transplantation CHU Pitié Salpetriere Paris
Paris, France, 75013
Actively Recruiting
6
Nephrologie hôpital Henri-Mondor
Paris, France, 94010 Créteil
Actively Recruiting
7
Nephrologie transplantation CHRU Poitiers
Poitiers, France, 86021
Actively Recruiting
8
Nephrologie transplantation CHRU Toulouse
Toulouse, France, 31059 Toulouse Cedex 9
Actively Recruiting
9
Nephrologie transplantation CHRU Tours
Tours, France, 37044
Actively Recruiting
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Research Team
A
Antoine Durrbach, MD-PhD
F
florence Herr, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study).
A Durrbach, J M Pestana, T Pearson...
https://pubmed.ncbi.nlm.nih.gov/20415898