NCT06641622

Brief Summary

Deceased donors and recipients who successfully completed kidney transplantation between 2016 and 2019 were included in this study. Donor plasma CIRBP levels were measured using an ELISA kit to evaluate their association with DGF incidence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 10, 2024

Last Update Submit

October 12, 2024

Conditions

Keywords

kidney transplantationcold-inducible RNA binding proteindelayed graft function

Outcome Measures

Primary Outcomes (1)

  • recipients developed delayed graft function

    DGF was defined as a decrease in daily plasma creatinine of less than 10% from the previous day for 3 consecutive days within 1 week postoperatively, or if serum creatinine (SCr) did not decrease to 400 μmol/L within 1 week after surgery

    within 1 week after surgery

Study Arms (2)

delayed graft function

DGF was defined as a decrease in daily plasma creatinine of less than 10% from the previous day for 3 consecutive days within 1 week postoperatively, or if serum creatinine (SCr) did not decrease to 400 μmol/L within 1 week after surgery

Diagnostic Test: Prediction of delayed graft function

immediate graft function

Recipients who did not develop DGF were categorized as IGF

Interventions

Donor plasma CIRBP levels were measured using an ELISA kit to evaluate their association with DGF incidence

delayed graft function

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Our study was a retrospective open cohort study that included deceased patients from January 2016 to December 2019. It adhered to the guidelines of the National Program for Deceased Organ Donation in China and involved successful kidney donors from the Third Affiliated Hospital of Sun Yat-sen University.

You may qualify if:

  • Kidney donors who meet the criteria for donation;
  • First-time kidney transplant recipients;
  • Transplantation using cadaveric donor kidneys;
  • Signing of the Human Organ Donation Relative Acknowledgement Registration Form.

You may not qualify if:

  • those without a blood specimen;
  • contamination of the blood specimen affecting the CIRBP level;
  • recipients of combined multi-organ transplants;
  • those participating in other clinical trials;
  • the existence of a previous history of other organ transplants;
  • any other condition that, in the opinion of the investigator, makes enrolment unsuitable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (2)

  • Yang R, Zhan M, Nalabothula NR, Yang Q, Indig FE, Carrier F. Functional significance for a heterogenous ribonucleoprotein A18 signature RNA motif in the 3'-untranslated region of ataxia telangiectasia mutated and Rad3-related (ATR) transcript. J Biol Chem. 2010 Mar 19;285(12):8887-93. doi: 10.1074/jbc.M109.013128. Epub 2010 Jan 26.

    PMID: 20103595BACKGROUND
  • Leng Q, Ma M, Tang Z, Jiang W, Han F, Huang Z. Assessing donor kidney function: the role of CIRBP in predicting delayed graft function post-transplant. Front Immunol. 2025 Jan 17;15:1518279. doi: 10.3389/fimmu.2024.1518279. eCollection 2024.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qianghua Leng

    Third Affiliated Hospital, Sun Yat-Sen University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

December 1, 2023

Primary Completion

August 10, 2024

Study Completion

October 10, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Share the data on Public management platform for clinical trials ResMan

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
March 2025, for 3 years

Locations