Incidence, Course and Outcome of ABMR in Kidney Transplantation

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

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.

Inclusion Criteria:

• Kidney transplant recipients ≥18 years old

• About to receive a post mortal or living donor renal transplant

• written informed consent (is able to read of understand in Dutch)

• Immunological high risk for rejection

  1. Luminex positive DSAs ; or
  2. Retransplantation with repeated mismatch ; or
  3. Husband to wife donation (after fathering children); or
  4. Offspring to mother donation

Exclusion Criteria:

• No immunological high risk