An observational study in Occurrence of Renal Dysfunction (GFR ≤ 60mL/(Min·1.73m2)) in Renal Transplant Recipients Within One Year After Kidney Transplantation, sponsored by Bei Wang. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Bei Wang · Observational
The objective of this observational study is to investigate the multimodal ultrasound parameters of kidneys from brain-dead organ donors prior to donation, in order to construct a predictive model for assessing the risk of early transplant renal dysfunction after kidney transplantation in recipients.
The primary question this study aims to address is:
Can multimodal ultrasound data from brain-dead organ donor kidneys accurately predict early post-transplant renal dysfunction?
Ultrasonography, as a routine examination before organ donation, will be utilized, and the study results will be concluded within one year after participation in this study.
This is the only study on the registry with Bei Wang as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Brain-deceased organ donors and their matched kidney transplant recipients at the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province).
Underwent allogeneic kidney transplantation at this hospital;
Signed informed consent form.
Donor Study Participants Brain-deceased organ donors;
Completed organ donation at the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province);
Brain death criteria:
Deep coma (with clear etiology and exclusion of reversible causes);
Absence of brainstem reflexes;
No spontaneous respiration;
Confirmed by at least two confirmatory tests (SLSEP, EEG, TCD), with re-evaluation 12 hours after the initial determination.
Standard Criteria Donor (SCD):
Age 10-39 years;
Cause of death unrelated to cerebrovascular disease;
Serum creatinine \<133 μmol/L;
Expanded Criteria Donor (ECD):
Age >60 years; OR
② Age 50-59 years with two of the following three criteria:
Cause of death related to cerebrovascular disease;
Serum creatinine \<133 μmol/L;
Signed informed consent form.
Exclusion Criteria:
Patients with follow-up duration less than 1 year;
Patients experiencing irreversible loss of graft function due to postoperative complications (e.g., rejection, thrombosis, anastomotic stenosis, infection).
Donor Study Participants Severe primary renal diseases (e.g., hypertensive nephropathy, diabetic nephropathy, renal tumors);
Cases with unavailable ultrasound imaging data:
Excessive respiratory motion in donors;
Obesity or other factors affecting imaging quality.
Individuals with allergic predisposition.
Multimodal ultrasound data collection will be conducted on all organ donors meeting the research criteria.
chronic allograft dysfunction
Occurrence of chronic allograft dysfunction (GFR ≤ 60mL/(min·1.73m2)) in renal transplant recipients within one year after kidney transplantation.
Time frame: Development of chronic allograft dysfunction within one year following kidney transplantation.
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