Incidence, Course and Outcome of ABMR in Kidney Transplantation (PROCARE2)

University Medical Center Groningen (UMCG)

Status: Enrolling

Conditions: Antibody-mediated Rejection; Kidney Transplantation; Immunosuppression

Treatments: Combination Product: Immunosuppression; Procedure: Nephrectomy (kidney donation); Procedure: Kidney Transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT05140018

PROCARE2

Details and patient eligibility

About

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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

225 participants in 2 patient groups

Kidney Transplant Recipients with an immunological high risk for ABMR

Description:

* Kidney transplant recipients ≥18 years old * About to receive a post mortal or living donor renal transplant * 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

Treatment:

Procedure: Kidney Transplantation

Combination Product: Immunosuppression

Living Kidney Donors

Description:

Participants who are about to donate their kidney to a Recipient with a high immunological risk (as described above)

Treatment:

Procedure: Nephrectomy (kidney donation)