Occurrence of Renal Dysfunction (GFR ≤ 60mL/(Min·1.73m2)) in Renal Transplant Recipients Within One Year After Kidney TransplantationNCT07090512
Multimodal Ultrasound in DBD Kidneys for Predicting Early Postoperative Renal Insufficiency Risk
An observational study of Occurrence of Renal Dysfunction (GFR ≤ 60mL/(Min·1.73m2)) in Renal Transplant Recipients Within One Year After Kidney Transplantation, run by Bei Wang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occurrence of Renal Dysfunction (GFR ≤ 60mL/(Min·1.73m2)) in Renal Transplant Recipients Within One Year After Kidney Transplantation
- What is being tested?
- Multimodal Ultrasound
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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).
Who may be able to join
- Recipient Study Participants Age ≥18 years;
- 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:
Show all 22Show fewer
- 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;
- No history of hypertension.
- 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;
- History of hypertension.
- Signed informed consent form.
Who cannot join
- Recipient Study Participants Patients with multiple kidney transplants;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000
About this study
Official title: Multimodal Ultrasound Assessment of Kidneys From Donation After Brain Death (DBD) to Predict the Risk Model of Early Postoperative Renal Insufficiency in Renal Transplantation
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.
- Being tested
- Multimodal Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal UltrasoundDiagnostic test
Multimodal ultrasound data collection will be conducted on all organ donors meeting the research criteria.
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic allograft dysfunction
Occurrence of chronic allograft dysfunction (GFR ≤ 60mL/(min·1.73m2)) in renal transplant recipients within one year after kidney transplantation.
Measured: Development of chronic allograft dysfunction within one year following kidney transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occurrence of Renal Dysfunction (GFR ≤ 60mL/(Min·1.73m2)) in Renal Transplant Recipients Within One Year After Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bei Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bei Wang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090512
- Sponsor's protocol ID
- YXLL-KY-2024(172)
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Ultrasound Assessment of Kidneys From Donation After Brain Death (DBD) to Predict the Risk Model of Early Postoperative Renal Insufficiency in Renal Transplantation
- ClinicalTrials.gov ID
- NCT07090512
- Acronym / sponsor ID
- YXLL-KY-2024(172)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Bei WangUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (22 listed)
- Recipient Study Participants Age ≥18 years;
- 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);
Key exclusion criteria (8 listed)
- Recipient Study Participants Patients with multiple kidney transplants;
- 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);
- Excessive respiratory motion in donors;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal UltrasoundMultimodal ultrasound data collection will be conducted on all organ donors meeting the research criteria. | Diagnostic test | – |
Primary outcome
chronic allograft dysfunction
Time frame: Development of chronic allograft dysfunction within one year following kidney transplantation.
Occurrence of chronic allograft dysfunction (GFR ≤ 60mL/(min·1.73m2)) in renal transplant recipients within one year after kidney transplantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occurrence of Renal Dysfunction (GFR ≤ 60mL/(Min·1.73m2)) in Renal Transplant Recipients Within One Year After Kidney Transplantation, run by Bei Wang 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 22 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bei Wang (（86）+18853182401, wangbei1224@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic allograft dysfunction (time frame: Development of chronic allograft dysfunction within one year following kidney transplantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2025.