BAFF/APRIL in Kidney Transplant Rejection Risk Assessment (BA-TRAP)

March 19, 2023 updated by: Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University
        • Principal Investigator:
          • Changxi Wang, M.D., Ph.D
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Kidney transplantation recipients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Antibody-mediated Rejection
Time Frame: 24 months
Antibody-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient survival
Time Frame: 24 months
24 months
Incidence of de novo donor-specific antibody
Time Frame: 24 months
Donor-specific antibody is monitored before transplantation and every six months after transplantation.
24 months
Incidence of T cell-mediated rejection
Time Frame: 24 months
T cell-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria
24 months
Incidence of infection
Time Frame: 24 months
24 months
Estimated glomerular filtration rate (eGFR)
Time Frame: 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.
24 months
Qualitative or Quantitative meassurement of urine protein
Time Frame: 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.
24 months
Renal graft survival
Time Frame: 24 months
Graft loss is defined as return to dialysis, removal of renal graft or kidney re-transplantation.
24 months
Death-censored renal graft survival
Time Frame: 24 months
Death-censored renal graft survival is defined as graft survival censored for death with a functioning graft
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborators

Nanfang Hospital of Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangdong Provincial People's Hospital
Zhujiang Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Second Affiliated Hospital of Guangzhou Medical University
Shenzhen Third People's Hospital
The Shenzhen's People's Hospital

Investigators

  • Study Chair: Changxi Wang, M.D., Ph.D., First affiliated hospital of Sun Yet-Sen university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

May 1, 2026

Study Completion (Anticipated)

May 1, 2026

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 19, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 19, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • sBA-KTX-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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