Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
All kidney transplant recipients undergoing a kidney allograft biopsy for a duration of five years in a single kidney transplantation center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood draw, Urine draw
Biological/VaccineCollection 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
Treatment groups
570 Participants
are divided into 2 treatment groupsGroup A: Patients with microvascular inflammation1 intervention
Group B: Patient without microvascular inflammation1 intervention
Trial outcomes
Primary outcomes
1
Number of circulating CD3- CD56+ cells
Comparison between patients with microvascular inflammation and other patients
Time frame
Day of inclusion sample (= day of kidney allograft biopsy)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: