Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation (RECITE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Transplantation; Humoral Rejection; Kidney Allograft Biopsy; Microvascular Inflammation
• Intervention / Treatment: Biological: Blood draw, Urine draw

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

• Study Type: Observational
• Enrollment (Estimated): 570

Contacts and Locations

• Study Contact: Name: Sophie CAILLARD-OHLMANN, PU-PH; Phone Number: 03 69 55 05 11; Email: sophie.caillard@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All kidney transplant recipients undergoing a kidney allograft biopsy for a duration of five years in a single kidney transplantation center.

Description

Inclusion Criteria:

• Kidney transplant recipient, male or female, 18 years of age or older
• Patient undergoing a kidney allograft biopsy, according to the usual protocol of the service
• Subject affiliated with a social health insurance scheme.
• Subject capable of understanding the objectives and risks associated with the research and expressing non-opposition

Exclusion Criteria:

• Inability to provide the subject with clear and proper information (difficulties in understanding the subject, ...)
• Refusal of the patient to participate in the study
• Subject under guardianship or curatorship
• Subjects under legal protection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with microvascular inflammation; Patients presenting with microvascular inflammation on kidney allograft biopsy	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
Patient without microvascular inflammation; Patients presenting without microvascular inflammation on kidney allograft biopsy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of circulating CD3- CD56+ cells	Comparison between patients with microvascular inflammation and other patients	Day of inclusion sample (= day of kidney allograft biopsy)

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): July 1, 2033

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Kidney Transplantation; Alloimmunization; Humoral rejection; Kidney allograft biopsy; Genetic incompatibilities
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 8968

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No