Impact of the Microbiota on the Likelihood of Renal Graft Rejection
Launched by INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE, FRANCE · Jan 29, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating how the gut bacteria in our bodies may affect the likelihood of kidney transplant rejection. The researchers are specifically looking for a certain bacterial pattern in the blood or stool of patients who have received a kidney transplant and are being treated with a medication called Nulojix during their first year after the transplant. By identifying this bacterial signature, they hope to better understand and predict when a transplant might be rejected.
If you are interested in participating, you must be scheduled for a kidney transplant and will be receiving specific treatments that include Simulect and Nulojix, along with other medications. The trial is open to people aged between 65 and 74 years or 25 and 66 years, and anyone can join regardless of gender. However, certain conditions like having multiple transplants, current infections, or being pregnant may prevent you from participating. If you join, you can expect to provide blood or stool samples to help researchers gather the needed information. It’s important to note that your participation could contribute to improving care for future kidney transplant patients.
Gender
ALL
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
About Institut National De La Santé Et De La Recherche Médicale, France
The Institut National de la Santé et de la Recherche Médicale (INSERM) is France's key public research organization dedicated to advancing knowledge in health and biomedical sciences. Established to foster innovation and improve public health outcomes, INSERM conducts a wide range of clinical trials and research initiatives aimed at translating scientific discoveries into effective medical treatments and interventions. With a focus on collaboration among researchers, healthcare professionals, and industry partners, INSERM plays a pivotal role in shaping health policies and enhancing the quality of care in France and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Besançon, , France
La Tronche, , France
Nantes, , France
Paris, , France
Paris, , France
Paris, , France
Poitiers, , France
Toulouse, , France
Tours, , France
Patients applied
Trial Officials
Antoine Durrbach, MD-PhD
Principal Investigator
Institut National de la Santé Et de la Recherche Médicale, France
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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