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Incidence, Course and Outcome of ABMR in Kidney Transplantation — PROCARE2  

Kidney Transplantation Clinical Trial

Official title:
Incidence, Course and Outcome of Cellular and Antibody-mediated Rejection in Immunological High-risk Kidney Transplantation, a Prospective Cohort PROCARE2 Study

Clinical Trial Summary

Rationale: Despite improved patient and graft survival in renal transplant recipients, still 20% of the patients reaches end-stage renal disease within 5 years after transplantation. Antibody-mediated rejection (ABMR) is one of the major causes of early graft loss and perhaps even more important of late deterioration of graft function Objective: Evaluate the occurrence of antibody mediated rejection (ABMR) and mixed ABMR and cellular/ T-cell mediated rejection (TCMR), in patients treated with the currently prevailing immunosuppressive regimens, and relate them to outcome (graft survival, function, proteinuria, histology) Study design: Clinical cohort study. Study population: patients of >18 years old, about to receive a post mortal of living donor renal transplant with an immunological high risk for ABMR. Main study parameters/endpoints: main study endpoints are the occurrence of ABMR, mixed ABMR/TCMR and renal function after 1 year of follow-up. The main study parameter will be mapping the immune system, including B-cells, (non-)HLA antibodies, interaction between B-cells and T follicular helper cells, and complete immune profiling.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05140018
Study type Observational
Source University Medical Center Groningen
Contact Jan-Stephan Sanders, MD PhD
Phone +31503612955
Email j.sanders@umcg.nl
Status Recruiting
Phase
Start date January 1, 2022
Completion date March 1, 2026
View Details
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