BAFF/APRIL in Kidney Transplant Rejection Risk Assessment

Study Overview
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Brief Summary
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Antibody-mediated rejection (AMR) is a significant risk factor for graft loss in kidney transplantation. Soluble B cell-activating factor (sBAFF) and a proliferation-inducing ligand (APRIL) plays a critical role in the activation and differentiation of B cells, making it a potential predictive biomarker for AMR. In this prospective multicenter cohort study, the effectiveness of sBAFF/APRIL in predicting AMR after kidney transplantation is evaluated. Recipient sBAFF/APRIL levels are monitored before transplantation, and at seven days, two weeks, one month, three months, and every three months after transplantation continuously . The primary outcome is the occurrence of AMR, while the status of donor-specific antibodies (DSA), T cell-mediated rejection (TCMR), and other clinical parameters are secondary outcomes. The predictive capacity of sBAFF/APRIL for both the primary and secondary outcomes will be investigated.

Official Title
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Soluble B-Cell Activating Factor and a Proliferation-inducing Ligand for Transplant Risk Assessment and Prediction of Antibody-Mediated Rejection in Kidney Transplantation: a Prospective Multicenter Cohort Study

Conditions
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Kidney Transplantation, Kidney Transplant Rejection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living donor or deceased donor kidney recipients. Patient is willing and capable of giving written informed consent for participation and able to participate in the study for 24 months. Exclusion Criteria: Preoperative donor specific antibody positive . Combined or multi-organ transplantation. Poor compliance. Unable to continue the follow-up. Patients who are judged by the doctors to be excluded for this trial (Details need to be provided).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Antibody-mediated Rejection | Antibody-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of de novo donor-specific antibody | Donor-specific antibody is monitored before transplantation and every six months after transplantation. | 24 months | 
| Incidence of T cell-mediated rejection | T cell-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria | 24 months | 
| Incidence of infection |  | 24 months | 
| Estimated glomerular filtration rate (eGFR) | eGFR is calculated based on Modification of Diet in Renal Disease (MDRD) formula, at one week, two weeks, one month, 3 months and every 3 months later, after kidney transplantation. | 24 months | 
| Qualitative or Quantitative meassurement of urine protein | Urine protein test result is collected at one week, two weeks, one month, 3 months and every 3 months later, after kidney transplantation. | 24 months | 
| Renal graft survival | Graft loss is defined as return to dialysis, removal of renal graft or kidney re-transplantation. | 24 months | 
| Death-censored renal graft survival | Death-censored renal graft survival is defined as graft survival censored for death with a functioning graft | 24 months | 
| Patient survival |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplantation, soluble B lymphocyte activating factor, antibody-mediated rejection, a proliferation-inducing ligand