NCT05890430

Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation

Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation "REjet Cellules Immunitaires Transplantation rEnale" (RECITE)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 570 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We will study a prospective cohort including all kidney transplant recipients undergoing kidney graft biopsy in one kidney transplantation center, for a duration of 5 years. Our primary outcome is to compare the number of circulating NK cells between patients and without humoral rejection. Our secondary outcomes are to describe the cellular, genetic, humoral, and histological characteristics of humoral rejection and their evolution.

Detailed description

Information and inclusion visit (V0) The information and inclusion visit will be carried out on the day of the graft biopsy or, in the case of pre-scheduled biopsies, during a consultation prior to the biopsy (still as part of standard follow-up). This is particularly the case for patients undergoing systematic biopsy. The indication for graft puncture-biopsy is generally decided by the nephrologist in charge of the patient, or at departmental meetings for complex cases. During this consultation, the physician verifies the inclusion criteria and obtains the patient's consent to take part in the study. We explain to the patient the scientific interest of evaluating the immune response in humoral rejection, and the absence of repercussions for the patient's subsequent management. A routine clinical examination is performed, and the patient's current treatment regimen is notified. If the patient agrees, a blood sample is taken for the standard biology follow-up of transplant patients and for the study samples: * Serum factors: 4 dry tubes or SST or EDTA 5 ml maximum * PBMCs: 8 heparinized tubes of 10 ml maximum, which may be replaced by Paxgen tubes in case of technical or logistical necessity * Urine: 5 dry tubes or SST 5 ml maximum Patients will be divided into two groups according to the indication for biopsy, with an influence on follow-up: * patients who underwent systematic biopsy (M3 and M12) * patients included in a biopsy for cause, whatever the distance to the graft Follow-up visits (V1, V2, V3, etc.) Subsequently, new samples may be offered to included patients, in order to compare the parameters studied at the time of and after their graft biopsies. The different follow-up times are indexed to the standard follow-up of kidney transplant patients. -Patients routinely biopsied between M0 and M6 of transplantation (most often M3): Follow-up will be indexed to post-transplant consultation follow-up. New samples may be taken at M6, M9, M12 (at the time of the second systematic biopsy), M18, M24 of transplantation or during a follow-up biopsy. Patients biopsied for cause, at any time post-transplant: follow-up will be indexed to the completion of patient follow-up consultations. New samples may be taken at M3, M6, M9, M12, M18, M24 after the biopsy, or during a follow-up biopsy. With the patient's consent, blood and urine samples are taken for the standard follow-up biology of transplant patients and for the study samples: * Serum factors: 4 dry tubes or SST or EDTA 5 ml maximum * PBMCs: 8 heparinized tubes of 10 ml maximum, which may be replaced by Paxgen tubes in case of technical or logistical necessity * Urines: 5 dry tubes or SST 5 ml

Conditions

• Kidney Transplantation
• Kidney Allograft Biopsy
• Humoral Rejection
• Microvascular Inflammation

Interventions

Type	Name	Description
BIOLOGICAL	Blood draw, Urine draw	Collection of an additional volume of blood at each follow-up time in addition to the standard blood test performed during the patient's follow-up Collection of an additional volume of urine at each follow-up time

Timeline

• Start date: 2023-06-01
• Primary completion: 2033-06-01
• Completion: 2033-07-01
• First posted: 2023-06-06
• Last updated: 2023-06-08