Incidence, Course and Outcome of ABMR in Kidney Transplantation

Kidney Transplantation Clinical Trial

— PROCARE2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140018
• Other study ID #: PROCARE2
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2023
• Source: University Medical Center Groningen
• Contact: Jan-Stephan Sanders, MD PhD
• Phone: +31503612955
• Email: j.sanders[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: March 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibody-mediated Rejection
• Immunosuppression
• Kidney Transplantation

Intervention

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

Locations

Country	Name	City	State
Netherlands	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

Sponsors (8)

Lead Sponsor	Collaborator
University Medical Center Groningen	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Dutch Kidney Foundation, Erasmus Medical Center, Leiden University Medical Center, Maastricht University Medical Center, Radboud University Medical Center, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Antibody-Mediated Rejection (ABMR)	Incidence of Antibody-Mediated Rejection (ABMR) as histopathological diagnosis	within 12 months after transplantation
Primary	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
Primary	Kidney transplant function	as measured by eGFR and proteinuria	at 12 months after transplantation
Secondary	Development of Human-Leukocyte Antigen (HLA) antibodies	As measured by Luminex assay at 3 and 12 months	At 3 and 12 months after transplantation
Secondary	Development of non-HLA antibodies	Development of non-HLA antibodies as measured by a cell-based endothelial assay	At 3 and 12 months after transplantation
Secondary	Kidney transplant survival	Kidney transplant survival in patients experiencing ABMR versus those not experiencing ABMR	At 12 months after transplantation