BAFF/APRIL in Kidney Transplant Rejection Risk Assessment

NCT ID: NCT05779124

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-05-01

Brief Summary

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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

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Conditions

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Kidney Transplantation Kidney Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

The Shenzhen's People's Hospital

UNKNOWN

Sponsor Role collaborator

Shenzhen Third People's Hospital

OTHER

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Changxi Wang

Director of Department of Kidney Transplantation, Organ Transplant Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Changxi Wang, M.D., Ph.D.

Role: STUDY_CHAIR

First affiliated hospital of Sun Yet-Sen university

Locations

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The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Changxi Wang, M.D., Ph.D.

Role: CONTACT

86-20-87755766

Huanxi Zhang, M.D, Ph.D.

Role: CONTACT

86-20-87306082

Facility Contacts

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Changxi Wang, M.D., Ph.D

Role: primary

86-20-87333428

Huanxi Zhang, M.D., Ph.D

Role: backup

86-20-87306082

References

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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.

Reference Type BACKGROUND
PMID: 35493478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31865240 (View on PubMed)

Other Identifiers

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sBA-KTX-2023

Identifier Type: -

Identifier Source: org_study_id

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