BAFF/APRIL in Kidney Transplant Rejection Risk Assessment

N/ANot Yet RecruitingNCT05779124

First Affiliated Hospital, Sun Yat-Sen University176 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

176

Conditions

Kidney Transplantation Kidney Transplant Rejection

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Living donor or deceased donor kidney recipients. 2. Patient is willing and capable of giving written informed consent for participation and able to participate in the study for 24 months. Exclusion Criteria: 1. Preoperative donor specific antibody positive . 2. Combined or multi-organ transplantation. 3. Poor compliance. 4. Unable to continue the follow-up. 5. Patients who are judged by the doctors to be excluded for this trial (Details need to be provided).

Outcomes

Primary Outcomes

Incidence of Antibody-mediated Rejection

Antibody-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria

Time frame: 24 months

Secondary Outcomes

Incidence of de novo donor-specific antibody

Donor-specific antibody is monitored before transplantation and every six months after transplantation.

Time frame: 24 months

Incidence of T cell-mediated rejection

T cell-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria

Time frame: 24 months

Incidence of infection

Time frame: 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.

Time frame: 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.

Time frame: 24 months

Renal graft survival

Graft loss is defined as return to dialysis, removal of renal graft or kidney re-transplantation.

Time frame: 24 months

Death-censored renal graft survival

Death-censored renal graft survival is defined as graft survival censored for death with a functioning graft

Time frame: 24 months

Patient survival

Time frame: 24 months

BAFF/APRIL in Kidney Transplant Rejection Risk Assessment

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts