Understanding how gut bacteria affect kidney transplant rejection
Impact of the Microbiota on the Likelihood of Renal Graft Rejection
This study is trying to see if certain gut bacteria in kidney transplant patients can help predict if they will experience rejection of their new kidney during the first year after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 9 sites (Besançon and 8 other locations) |
| Trial ID | NCT04736381 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify a specific bacterial signature in the blood or stool of kidney transplant patients that may be linked to acute rejection during their first year post-transplant. Researchers will analyze the gut microbiota and the presence of 16S plasma bacterial DNA and metabolites at the time of transplantation and throughout the first year. Additionally, the study will examine the phenotype of the patients' T lymphocytes to correlate these findings with instances of acute cell rejection. The approach focuses on patients treated with Nulojix as part of their immunosuppressive regimen.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for a kidney transplant who will receive Nulojix as part of their immunosuppressive therapy.
Not a fit: Patients with multiple grafts, those undergoing induction therapy with polyclonal antibodies, or those with active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and prevention strategies for kidney transplant rejection based on microbiota profiles.
How similar studies have performed: While the role of microbiota in transplant outcomes is an emerging field, this specific approach to correlating microbiota signatures with kidney transplant rejection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Besançon and 8 other locations
- Nephrologie transplantation CHRU Besançon — Besançon, France (Recruiting)
- Néphrologie, hémodialyse, aphérèses, transplantation rénale — La Tronche, France (Recruiting)
- Nephrologie transplantation CHRU Nantes — Nantes, France (Recruiting)
- Nephrologie transplantation CHU Saint Louis Paris — Paris, France (Recruiting)
- Nephrologie transplantation CHU Pitié Salpetriere Paris — Paris, France (Recruiting)
- Nephrologie hôpital Henri-Mondor — Paris, France (Recruiting)
- Nephrologie transplantation CHRU Poitiers — Poitiers, France (Recruiting)
- Nephrologie transplantation CHRU Toulouse — Toulouse, France (Recruiting)
- Nephrologie transplantation CHRU Tours — Tours, France (Recruiting)
Study contacts
- Principal investigator: Antoine Durrbach, MD-PhD — Institut National de la Santé Et de la Recherche Médicale, France
- Study coordinator: Antoine Durrbach, MD-PhD
- Email: antoine.durrbach@inserm.fr
- Phone: +33614112981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.