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Kidney TransplantationBA-TRAPNCT05779124

BAFF/APRIL in Kidney Transplant Rejection Risk Assessment

An observational study of Kidney Transplantation and Kidney Transplant Rejection, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
How many people
176 participants
Where
1 siteChina
Study dates
1 May 2023to 1 May 2026
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Kidney transplantation recipients

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

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

86-20-87755766

wangchx@mail.sysu.edu.cn

Huanxi Zhang, M.D, Ph.D. contact

86-20-87306082

zhanghx37@mail.sysu.edu.cn

China1 site

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Changxi Wang, M.D., Ph.D, 86-20-87333428, wangchx@mail.sysu.edu.cn

    Huanxi Zhang, M.D., Ph.D, 86-20-87306082, zhanghx37@mail.sysu.edu.cn

Other trials in China

About this study

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

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.

Keywords
kidney transplantation, soluble B lymphocyte activating factor, antibody-mediated rejection, a proliferation-inducing ligand

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Antibody-mediated Rejection

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

    Measured: 24 months

Secondary outcomes (8)

  1. Incidence of de novo donor-specific antibody

    Donor-specific antibody is monitored before transplantation and every six months after transplantation.

    Measured: 24 months

  2. Incidence of T cell-mediated rejection

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

    Measured: 24 months

  3. Incidence of infection

    Measured: 24 months

  4. 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.

    Measured: 24 months

  5. 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.

    Measured: 24 months

  6. Renal graft survival

    Graft loss is defined as return to dialysis, removal of renal graft or kidney re-transplantation.

    Measured: 24 months

  7. Death-censored renal graft survival

    Death-censored renal graft survival is defined as graft survival censored for death with a functioning graft

    Measured: 24 months

  8. Patient survival

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
176 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05779124
Sponsor's protocol ID
sBA-KTX-2023
Acronym
BA-TRAP
Status last verified
Mar 2023
First submitted
3 Mar 2023
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35493478

  • 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.

    PubMed 31865240

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplantation and Kidney Transplant Rejection, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Changxi Wang, M.D., Ph.D. (86-20-87755766, wangchx@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Antibody-mediated Rejection (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05779124, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.

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