Incidence, Course and Outcome of ABMR in Kidney Transplantation

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.

Conditions

• Antibody-mediated Rejection
• Kidney Transplantation
• Immunosuppression

Interventions

PROCEDURE

Kidney Transplantation

All participants will receive a kidney transplantation from a living donor or deceased donor

COMBINATION_PRODUCT

Immunosuppression

All participants will receive immunosuppresive drugs to prevent rejection of de kidney transplant graft.

PROCEDURE

Nephrectomy (kidney donation)

All kidney donors will receive a nephrectomy for kidney donation

Sponsors & Collaborators

• Dutch Kidney Foundation

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Hendrikus Otten, PhD · UMC Utrecht

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2025-01-01

Completion

2026-03-01

Countries

• Netherlands

Study Locations