Blood draw, Urine draw
BiologicalCollection 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
NCT Number: NCT05890430
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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:
Patients will be divided into two groups according to the indication for biopsy, with an influence on follow-up:
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Day of inclusion sample (= day of kidney allograft biopsy)
Comparison between patients with microvascular inflammation and other patients
Contact information is provided by the study sponsor or research team.
University Hospital, Strasbourg, France
Other
Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation "REjet Cellules Immunitaires Transplantation rEnale" (RECITE)
Acronym: RECITE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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