BAFF/APRIL in Kidney Transplant Rejection Risk Assessment | NCT05779124

Studies
BAFF/APRIL in Kidney Transplant Rejection Risk Assessment

NCT05779124

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Mar 22, 2023Actual

Enrollment

176Estimated

Phase

Not provided

Conditions

Kidney Transplantation
Kidney Transplant Rejection

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Estimated

Primary Completion Date

May 1, 2026Estimated

Completion Date

May 1, 2026Estimated

First Submitted Date

Mar 3, 2023

First Submission Date that Met QC Criteria

Mar 19, 2023

First Posted Date

Mar 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2023

Last Update Posted Date

Mar 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Changxi Wang, Director of Department of Kidney Transplantation, Organ Transplant Center, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Name	Class
Fifth Affiliated Hospital, Sun Yat-Sen University	OTHER
Guangdong Provincial People's Hospital	OTHER
Nanfang Hospital, Southern Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

176Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Incidence of de novo donor-specific antibody	Donor-specific antibody is monitored before transplantation and every six months after transplantation.	24 months
Incidence of T cell-mediated rejection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Kidney transplantation recipients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Changxi Wang, M.D., Ph.D.	First affiliated hospital of Sun Yet-Sen university	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital, Sun Yat-sen University		Guangzhou	Guangdong	510080	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35493478	Background	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.
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