Clinical trial NCT05779124: BAFF/APRIL in Kidney Transplant Rejection Risk Assessment
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Kidney Transplantation
Kidney Transplant Rejection
Keywords: kidney transplantation
soluble B lymphocyte activating factor
antibody-mediated rejection
a proliferation-inducing ligand
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: Guangdong Provincial People's Hospital
name: Nanfang Hospital, Southern Medical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Second Affiliated Hospital of Guangzhou Medical University
name: The Shenzhen's People's Hospital
name: Shenzhen Third People's Hospital
name: Zhujiang Hospital
First posted: 2023-03-22
Enrollment: 176
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney transplantation recipients

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of Antibody-mediated Rejection
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of de novo donor-specific antibody
timeFrame: 24 months
measure: Incidence of T cell-mediated rejection
timeFrame: 24 months
measure: Incidence of infection
timeFrame: 24 months
measure: Estimated glomerular filtration rate (eGFR)
timeFrame: 24 months
measure: Qualitative or Quantitative meassurement of urine protein
timeFrame: 24 months
measure: Renal graft survival
timeFrame: 24 months
measure: Death-censored renal graft survival
timeFrame: 24 months
measure: Patient survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First affiliated hospital of Sun Yet-Sen university
name: Changxi Wang, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Wu S, Su X, Ye Q, Wei Y, Gao Y, Huang M, Chen Y, Wang J, Zhang Q, Fu Q, Li J, Wu C, Huang H, Xu B, Zhang H, Liu L, Wang C. Serum Soluble B Cell-Activating Factor Is a Non-Invasive Biomarker of Antibody-Mediated Rejection in Kidney Allograft With Satisfactory Risk Stratification Performance But Negligible Diagnostic Value. Front Immunol. 2022 Apr 13;13:869444. doi: 10.3389/fimmu.2022.869444. eCollection 2022.
citation: Zhang H, Wang S, Su X, Fu Q, Li J, Wang J, Deng R, Wu C, Huang Q, Liu L, Wang C. The role of soluble B cell-activating factor in further stratifying the risk of antibody-mediated rejection post-renal transplant: A meta-analysis. Int Immunopharmacol. 2020 Feb;79:106059. doi: 10.1016/j.intimp.2019.106059. Epub 2019 Dec 20.