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CompletedNCT06641622Updated Oct 15, 2024

Study of the Correlation Between Donor CIRBP and Transplanted Kidney Function

An observational study in Kidney Transplant; Complications and Delayed Graft Function, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Completed at 1 site in China. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
207
Ages
10 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

The 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. Donors were excluded if they met any of the following conditions: (a) lacked a blood specimen; (b) had contaminated blood specimens affecting CIRBP levels; (c) were recipients who underwent combined multi-organ transplants; (d) were participating in other clinical trials; (e) had a history of organ transplantation; (f) had other conditions deemed unsuitable for enrollment by the investigator. Blood specimens were collected from donors by Organ Procurement Organizations (OPOs) and used for various studies with the donors' consent. All recipients (207 recipients, 207 donors) were followed up in the long term after transplantation.

The investigators followed the principles outlined in the Declaration of Helsinki (20) and the Declaration of Istanbul . Approval for this study was obtained from the Human Organ Transplantation and Ethics Committee of Sun Yat-sen University. The Ethics Committee was formed in compliance with the World Health Organization's Operational Guidelines for Ethics Committee Review of Biomedical Research. Organ allocation was performed in a fair and transparent manner via the Chinese Organ Transplant Response System. The type of donation was voluntarily determined by the donor's family, and the recipient underwent follow-up after transplantation. Both the donor's family and the recipient provided consent for the use of samples and clinical data in research.

Donor data were obtained from the China Organ Transplant Response System, completed by members of organ transplant organizations. Additionally, some donor information was supplemented from clinical electronic medical records. Recipient data were derived from clinical electronic records alone. Investigators categorized donors and recipients into delayed graft function (DGF) and immediate graft function (IGF) groups based on the recipient's early renal function status. 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. Recipients who did not develop DGF were categorized as IGF. Primary nonfunction (PNF) was diagnosed in patients requiring continuous dialysis after surgery or retransplantation. Additionally, expended criteria donors were defined as those aged over 60 years, or between 50 and 59 years meeting at least two of the following criteria: final serum creatinine > 133 μmol/L, cerebrovascular accident as the cause of death, and a history of hypertension.

Sample Collection Whole blood specimens were obtained from the donor in the operating theater before organ retrieval and transported on crushed ice to the laboratory, with an average transit duration of 2 hours. For serum preparation, the whole blood specimens were left at room temperature for 2 hours, then centrifuged at 1000 g for 15 minutes at a temperature of 2-8°C. The resulting supernatant was collected and stored at -80°C within the laboratory. Before testing, the serum samples were thawed on crushed ice and centrifuged again at 1000 g for 15 minutes at 2-8°C.

Measurement Of Cold Inducible RNA Binding Protein Level Serum CIRBP was detected using an ELISA kit (CSB-EL005440HU). The protein standard was diluted according to the instructions, and 100 µl of different concentrations of standard and samples (1:10 dilution) were added to a 96-well plate in duplicate. The plate was incubated at 37°C for 2 hours in the dark. Following incubation, the liquid in the wells was discarded, and 100 µl of biotin-labeled antibody working solution was added to each well. After incubating at 37°C for 1 hour, the plate was washed three times with washing solution. Subsequently, 100 µl of horseradish peroxidase-labeled affinity solution was added to each well. After an additional 1-hour incubation at 37°C, the plate was washed five times. Then, 90 µl of substrate solution was added to each well, and after a 15-minute color development at 37°C, 50 µl of termination solution was used to stop the reaction. The absorbance was measured at 450 nm within 5 minutes using a microplate reader, and concentrations were calculated based on the standard curve.

02

Conditions studied

  • Kidney Transplant; Complications
  • Delayed Graft Function

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Keywords

  • kidney transplantation
  • cold-inducible RNA binding protein
  • delayed graft function
03

In context

Delayed Graft Function

83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.

This study's enrollment of 207 is above the median of 125 across 16 observational studies indexed under Delayed Graft Function.

Browse Delayed Graft Function studies →

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 133 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
207 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testPrediction of delayed graft function

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

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What researchers measure

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

    Time frame: within 1 week after surgery

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Study locations

1 site
  • The Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
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References and documents

Publications

  • 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. PubMed 20103595 ↗

Individual participant data

Plan to share: Yes — Share the data on Public management platform for clinical trials ResMan

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: March 2025, for 3 years

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06641622
Responsible party
Qianghua Leng (Principal Investigator, Third Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Oct 15, 2024
Start date
Dec 1, 2023
Primary completion
Aug 10, 2024
Completion
Oct 10, 2024
Last update
Oct 15, 2024

Study contacts

Qianghua Leng
study director · Third Affiliated Hospital, Sun Yat-Sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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