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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05140018
Other study ID # PROCARE2
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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