NCT05785936

Immune Response in Desensitized Patients

Impact of Desensitization Therapies on the Immune Response of Highly Sensitized Patients Awaiting Kidney Transplantation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Kidney transplantation is the best treatment for chronic renal failure in terms of morbidity and mortality, quality of life for patients and health economics. Sensitization with anti-Human Leukocyte Antigen antibodies is a barrier to access to transplantation. Highly-sensitized patients wait 2 to 3 times longer on the waiting list with important health and economic consequences. Desensitization strategies by apheresis techniques allow access to a transplant with a negative crossmatch (absence of specific HLA antibodies against their donor) on the day of the transplant. The main objective of this study is to assess the impact of desensitization on the antibody memory immune response in highly sensitized patients awaiting kidney transplantation. The analyses will be based on samples from the 20 patients (10 desensitized transplanted patients, 5 highly sensitized non-desensitized transplanted patients and 5 healthy donors) at the University Hospital of Grenoble, France. Analyses will include phenotypic and immuno-metabolic analysis by flow cytometry of antibody-secreting cells, a functional analysis by anti HLA ELISpot B technique and histological analysis of post-kidney transplantation follow-up renal biopsies with gene expression mapping (RNA tissue labeling using the Nanostring technique) within the renal parenchyma.

Conditions

• Kidney Transplant Rejection

Interventions

Type	Name	Description
PROCEDURE	Desensitization	Patients that received apheresis and anti-cluster of differentiation antigen 20 for desensitization priori to kidney transplantation

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2023-03-27
• Last updated: 2023-03-29