NCT05779124

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

March 3, 2023

Last Update Submit

March 19, 2023

Conditions

Kidney TransplantationKidney Transplant Rejection

Keywords

kidney transplantationsoluble B lymphocyte activating factorantibody-mediated rejectiona proliferation-inducing ligand

Outcome Measures

Primary Outcomes (1)

  • Incidence of Antibody-mediated Rejection

    Antibody-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria

    24 months

Secondary Outcomes (8)

  • Incidence of de novo donor-specific antibody

    24 months

  • Incidence of T cell-mediated rejection

    24 months

  • Incidence of infection

    24 months

  • Estimated glomerular filtration rate (eGFR)

    24 months

  • Qualitative or Quantitative meassurement of urine protein

    24 months

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Kidney transplantation recipients

You may qualify if:

  • Living donor or deceased donor kidney recipients.
  • Patient is willing and capable of giving written informed consent for participation and able to participate in the study for 24 months.

You may not qualify if:

  • Preoperative donor specific antibody positive .
  • Combined or multi-organ transplantation.
  • Poor compliance.
  • Unable to continue the follow-up.
  • Patients who are judged by the doctors to be excluded for this trial (Details need to be provided).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related 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.

    PMID: 35493478BACKGROUND

  • 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.

    PMID: 31865240BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

We willl collect the peripheral blood samples from recipients for further biological research on the BAFF/APIRL pathway. The anonymized samples will be collected after obtaining informed consent.

Study Officials

  • Changxi Wang, M.D., Ph.D.

    First affiliated hospital of Sun Yet-Sen university

    STUDY CHAIR

Central Study Contacts

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

CONTACT

86-20-87755766wangchx@mail.sysu.edu.cn

Huanxi Zhang, M.D, Ph.D.

CONTACT

86-20-87306082zhanghx37@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Kidney Transplantation, Organ Transplant Center

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 22, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

CN(1)