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Clinical Trials in France / NCT04736381
Active, not recruiting Observational

Impact of the Microbiota on the Likelihood of Renal Graft Rejection

NCT04736381 · tracked via the Priya Life Science France tracker
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Phase
Observational
Started
2021-10-07
Last updated
2026-08-03

Condition(s) studied

Kidney Transplant Rejection

Investigational drug(s) / intervention(s)

Belatacept Injection [Nulojix] →

Belatacept Injection [Nulojix]: Drugs administrated are part of the usual care

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Acute rejection occurence — 1 year or rejection
    Occurence of cellular rejection according to the BANFF 2017

Trial sites (10)

FacilityCityRegionStatus
Nephrologie transplantation CHRU Besançon Besançon France
Néphrologie, hémodialyse, aphérèses, transplantation rénale La Tronche France
Nephrologie transplantation CHRU Nantes Nantes France
Nephrologie transplantation CHU Saint Louis Paris Paris France
Nephrologie transplantation CHU Pitié Salpetriere Paris Paris France
Service de néphrologie et transplantation adulte. Hôpital Necker Paris France
Nephrologie hôpital Henri-Mondor Paris France
Nephrologie transplantation CHRU Poitiers Poitiers France
Nephrologie transplantation CHRU Toulouse Toulouse France
Nephrologie transplantation CHRU Tours Tours France

More Institut National de la Santé Et de la Recherche Médicale, France trials in France

European Cystinosis Cohort 2 Starting soon
MPS (RaDiCo Cohort) (RaDiCo-MPS) Recruiting
CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome Recruiting
X-linked Moesin Associated Immunodeficiency Recruiting
Cerebello-motor Neuromodulation After Stroke. CERSTIM. Recruiting

Other trials for the same condition

A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation Recruiting
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients Enrolling by invitation
Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R) Starting soon
Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection Active, not recruiting
Clinical Impact of the IBox As an Early Intervention TooL Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04736381 on ClinicalTrials.gov ↗ ← All trials in France