Clinical trial NCT05140018: Incidence, Course and Outcome of ABMR in Kidney Transplantation
Official title: Incidence, Course and Outcome of Cellular and Antibody-mediated Rejection in Immunological High-risk Kidney Transplantation, a Prospective Cohort PROCARE2 Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Antibody-mediated Rejection
Kidney Transplantation
Immunosuppression
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Dutch Kidney Foundation
name: UMC Utrecht
name: Leiden University Medical Center
name: Maastricht University Medical Center
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Erasmus Medical Center
name: Radboud University Medical Center
First posted: 2021-12-01
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with eind-stage renale disease (ESRD) who are about to receive a kidney transplant from a living or deceased donor, with an elevated immunological risk (higher risk for (antibody-mediated) rejection).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Antibody-Mediated Rejection (ABMR)
timeFrame: within 12 months after transplantation
measure: Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection (ABMR/TCMR)
timeFrame: within 12 months after transplantation
measure: Kidney transplant function
timeFrame: at 12 months after transplantation
Secondary outcomes:
measure: Development of Human-Leukocyte Antigen (HLA) antibodies
timeFrame: At 3 and 12 months after transplantation
measure: Development of non-HLA antibodies
timeFrame: At 3 and 12 months after transplantation
measure: Kidney transplant survival
timeFrame: At 12 months after transplantation
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud University Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: UMCU
Study officials:
affiliation: UMC Utrecht
name: Hendrikus Otten, PhD
role: STUDY_CHAIR
References: