BAFF/APRIL in Kidney Transplant Rejection Risk Assessment

Kidney Transplantation Clinical Trial

— BA-TRAP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05779124
• Other study ID #: sBA-KTX-2023
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: March 2023
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Changxi Wang, M.D., Ph.D.
• Phone: 86-20-87755766
• Email: wangchx[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Kidney Transplant Rejection
• Kidney Transplantation

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (9)

Lead Sponsor	Collaborator
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, Second Affiliated Hospital of Guangzhou Medical University, Shenzhen Third People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Shenzhen's People's Hospital, Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Antibody-mediated Rejection	Antibody-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria	24 months
Secondary	Incidence of de novo donor-specific antibody	Donor-specific antibody is monitored before transplantation and every six months after transplantation.	24 months
Secondary	Incidence of T cell-mediated rejection	T cell-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria	24 months
Secondary	Incidence of infection		24 months
Secondary	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
Secondary	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
Secondary	Renal graft survival	Graft loss is defined as return to dialysis, removal of renal graft or kidney re-transplantation.	24 months
Secondary	Death-censored renal graft survival	Death-censored renal graft survival is defined as graft survival censored for death with a functioning graft	24 months
Secondary	Patient survival		24 months