BA-TRAP: BAFF/APRIL in Kidney Transplant Rejection Risk Assessment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Incidence of Antibody-mediated Rejection [24 months]
Antibody-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria
Secondary Outcome Measures
- Incidence of de novo donor-specific antibody [24 months]
Donor-specific antibody is monitored before transplantation and every six months after transplantation.
- Incidence of T cell-mediated rejection [24 months]
T cell-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria
- Incidence of infection [24 months]
- Estimated glomerular filtration rate (eGFR) [24 months]
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.
- Qualitative or Quantitative meassurement of urine protein [24 months]
Urine protein test result is collected at one week, two weeks, one month, 3 months and every 3 months later, after kidney transplantation.
- Renal graft survival [24 months]
Graft loss is defined as return to dialysis, removal of renal graft or kidney re-transplantation.
- Death-censored renal graft survival [24 months]
Death-censored renal graft survival is defined as graft survival censored for death with a functioning graft
- Patient survival [24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Living donor or deceased donor kidney recipients.
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Patient is willing and capable of giving written informed consent for participation and able to participate in the study for 24 months.
Exclusion Criteria:
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Preoperative donor specific antibody positive .
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Combined or multi-organ transplantation.
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Poor compliance.
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Unable to continue the follow-up.
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Patients who are judged by the doctors to be excluded for this trial (Details need to be provided).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | 510080 |
Sponsors and Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Guangdong Provincial People's Hospital
- Nanfang Hospital of Southern Medical University
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Second Affiliated Hospital of Guangzhou Medical University
- The Shenzhen's People's Hospital
- Shenzhen Third People's Hospital
- Zhujiang Hospital
Investigators
- Study Chair: Changxi Wang, M.D., Ph.D., First affiliated hospital of Sun Yet-Sen university
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- sBA-KTX-2023