BAFF/APRIL in Kidney Transplant Rejection Risk Assessment

Not yet recruiting

• Conditions: Kidney Transplant Rejection; Kidney Transplantation

• Registration Number: NCT05779124
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-19
• Last Update Submitted: 2023-03-19
• Study First Posted: 2023-03-22
• Last Update Posted: 2023-03-22
• Study Start: 2023-05-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 176

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Antibody-mediated Rejection	24 months	Antibody-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria

Secondary Outcome Measures

Name	Time	Method
Incidence of T cell-mediated rejection	24 months	T cell-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria
Renal graft survival	24 months	Graft loss is defined as return to dialysis, removal of renal graft or kidney re-transplantation.
Incidence of de novo donor-specific antibody	24 months	Donor-specific antibody is monitored before transplantation and every six months after transplantation.
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.
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

Trial Locations

Locations (1)

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China