Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation

NCT05890430 | Not Yet Recruiting

• 1 other identifier: 8968
• Study Type: observational
• Target: 570
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Kidney Transplantation; Humoral rejection; Kidney allograft biopsy; Alloimmunization; Genetic incompatibilities

Outcome Measures

Primary Outcomes (1)

• Number of circulating CD3- CD56+ cells

  Comparison between patients with microvascular inflammation and other patients

  Day of inclusion sample (= day of kidney allograft biopsy)

Study Arms (2)

Patients with microvascular inflammation

Patients presenting with microvascular inflammation on kidney allograft biopsy

Biological: Blood draw, Urine draw

Patient without microvascular inflammation

Patients presenting without microvascular inflammation on kidney allograft biopsy

Biological: Blood draw, Urine draw

Interventions

Blood draw, Urine draw BIOLOGICAL

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 with microvascular inflammation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Urine Graft biopsies

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Sophie CAILLARD-OHLMANN, PU-PH

CONTACT

03 69 55 05 11; sophie.caillard@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 6, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): July 1, 2033
• Last Updated: June 8, 2023

Record last verified: 2023-05