Incidence, Course and Outcome of Cellular and Antibody-mediated Rejection in Immunological High-risk Kidney Transplantation, a Prospective Cohort PROCARE2 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 6
- 主要终点
- Incidence of Antibody-Mediated Rejection (ABMR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •No immunological high risk
结局指标
主要结局
Incidence of Antibody-Mediated Rejection (ABMR)
时间窗: within 12 months after transplantation
Incidence of Antibody-Mediated Rejection (ABMR) as histopathological diagnosis
Kidney transplant function
时间窗: at 12 months after transplantation
as measured by eGFR and proteinuria
Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection (ABMR/TCMR)
时间窗: within 12 months after transplantation
Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection as histopathological diagnosis(ABMR/TCMR) as histopathological diagnosis
次要结局
- Kidney transplant survival(At 12 months after transplantation)
- 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)
研究者
J.S.F. Sanders
Principal Investigator
University Medical Center Groningen