NCT04736381 Impact of the Microbiota on the Likelihood of Renal Graft Rejection
| NCT ID | NCT04736381 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Kidney Transplant Rejection |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-10-07 |
| Primary Completion | 2027-01-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2021-10-07 with a primary completion date of 2027-01-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Antoine Durrbach, MD-PhD
PRINCIPAL INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
Frequently Asked Questions
Who can join the NCT04736381 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Kidney Transplant Rejection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04736381 currently recruiting?
Yes, NCT04736381 is actively recruiting participants. Contact the research team at antoine.durrbach@inserm.fr for enrollment information.
Where is the NCT04736381 trial being conducted?
This trial is being conducted at Besançon, France, La Tronche, France, Nantes, France, Paris, France and 5 additional locations.
Who is sponsoring the NCT04736381 clinical trial?
NCT04736381 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Antoine Durrbach, MD-PhD at Institut National de la Santé Et de la Recherche Médicale, France. The trial plans to enroll 70 participants.
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