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NCT05140018 | Recruiting | Antibody-mediated Rejection


Incidence, Course and Outcome of ABMR in Kidney Transplantation
Sponsor:

University Medical Center Groningen

Information provided by (Responsible Party):

J.S.F. Sanders

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.

Condition or disease

Antibody-mediated Rejection

Kidney Transplantation

Immunosuppression

Intervention/treatment

Kidney Transplantation

Immunosuppression

Nephrectomy (kidney donation)

Study Type : Observational
Estimated Enrollment : 225 participants
Official Title : Incidence, Course and Outcome of Cellular and Antibody-mediated Rejection in Immunological High-risk Kidney Transplantation, a Prospective Cohort PROCARE2 Study
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : March 1, 2026

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
  • Luminex positive DSAs ; or
  • Retransplantation with repeated mismatch ; or
  • Husband to wife donation (after fathering children); or
  • Offspring to mother donation
Exclusion Criteria
  • No immunological high risk

Incidence, Course and Outcome of ABMR in Kidney Transplantation

Location Details


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Incidence, Course and Outcome of ABMR in Kidney Transplantation

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Netherlands,

Academic Medical Centre

Amsterdam, Netherlands,

Recruiting

Netherlands,

University Medical Center Groningen

Groningen, Netherlands,

Recruiting

Netherlands,

Leiden University Medical Center

Leiden, Netherlands,

Recruiting

Netherlands,

Radboud University Hospital

Nijmegen, Netherlands,

Recruiting

Netherlands,

Erasmus MC

Rotterdam, Netherlands,

Recruiting

Netherlands,

UMC

Utrecht, Netherlands,

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