Impact of the Microbiota on the Likelihood of Renal Graft Rejection (MERRLIN)

Institut National de la Santé Et de la Recherche Médicale, France

Status: Enrolling

Conditions: Kidney Transplant Rejection

Treatments: Drug: Belatacept Injection [Nulojix]

Study type: Observational

Funder types: Other

Identifiers

NCT04736381

C 19-53

Details and patient eligibility

About

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.

Full description

Gut microbiota as well as the signature of the 16S plasma bacterial DNA and bacterial metabolites of patients on the date of transplantation and during the first year after transplantation will be analyzed. The phenotype of the patients' T lymphocytes will be analyzed at the same time. These data will be correlated with the occurrence of acute cell rejection during the first year of transplantation

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

Kidney transplanted patients treated with Nulojix

Description:

Patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant.

Treatment:

Drug: Belatacept Injection [Nulojix]