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Search / Trial NCT04736381

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

Microbiota Belatacept Second Signal Inhibitor

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.

Locations

Besançon, , France

La Tronche, , France

Nantes, , France

Paris, , France

Paris, , France

Paris, , France

Poitiers, , France

Toulouse, , France

Tours, , France

Patients applied

0 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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