NCT05140018

Incidence, Course and Outcome of ABMR in Kidney Transplantation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 225 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Antibody-mediated Rejection
• Kidney Transplantation
• Immunosuppression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-01-01
• Completion: 2026-03-01
• First posted: 2021-12-01
• Last updated: 2023-05-11

Locations

6 sites across 1 country: Netherlands