Incidence, Course and Outcome of ABMR in Kidney Transplantation
PROCARE2
1 other identifier
observational
225
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedMay 11, 2023
May 1, 2023
3 years
November 17, 2021
May 9, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence of Antibody-Mediated Rejection (ABMR)
Incidence of Antibody-Mediated Rejection (ABMR) as histopathological diagnosis
within 12 months after transplantation
Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection (ABMR/TCMR)
Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection as histopathological diagnosis(ABMR/TCMR) as histopathological diagnosis
within 12 months after transplantation
Kidney transplant function
as measured by eGFR and proteinuria
at 12 months after transplantation
Secondary Outcomes (3)
Development of Human-Leukocyte Antigen (HLA) antibodies
At 3 and 12 months after transplantation
Development of non-HLA antibodies
At 3 and 12 months after transplantation
Kidney transplant survival
At 12 months after transplantation
Study Arms (2)
Kidney Transplant Recipients with an immunological high risk for ABMR
* 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
Living Kidney Donors
Participants who are about to donate their kidney to a Recipient with a high immunological risk (as described above)
Interventions
All participants will receive a kidney transplantation from a living donor or deceased donor
All participants will receive immunosuppresive drugs to prevent rejection of de kidney transplant graft.
All kidney donors will receive a nephrectomy for kidney donation
Eligibility Criteria
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).
You may qualify if:
- 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
- Luminex positive DSAs ; or
- Retransplantation with repeated mismatch ; or
- Husband to wife donation (after fathering children); or
- Offspring to mother donation
You may not qualify if:
- No immunological high risk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Center Groningenlead
- Dutch Kidney Foundationcollaborator
- UMC Utrechtcollaborator
- Leiden University Medical Centercollaborator
- Maastricht University Medical Centercollaborator
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)collaborator
- Erasmus Medical Centercollaborator
- Radboud University Medical Centercollaborator
Study Sites (6)
Academisch Medisch Centrum
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Radboud University Hospital
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
UMCU
Utrecht, Netherlands
Biospecimen
Peripheral Blood Mononuclear Cells (PBMCs) Kidney biopsy material (in case when kidney biopsy is performed in the follow-up) Iliac lymph nodes from 15 selected kidney transplant recipients
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hendrikus Otten, PhD
UMC Utrecht
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 17, 2021
First Posted
December 1, 2021
Study Start
January 1, 2022
Primary Completion
January 1, 2025
Study Completion
March 1, 2026
Last Updated
May 11, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share