Chronic Kidney Disease(CKD)NCT06961162
The Accuracy of Ultrasonic Viscoelastic Imaging in Evaluating the Severity of Chronic Kidney Diseases
An observational study of Chronic Kidney Disease(CKD), run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the role of ultrasonic viscoelastic parameters in the assessing the severity of chronic kidney disease. The main question it aims to answer is: The accuracy of ultrasonic viscoelastic parameters in evaluating the degree of renal fibrosis and inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease(CKD)
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2023to 3 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: CKD patients who underwent renal biopsy at Peking University Third Hospital based on clinical requirements
Who may be able to join
- (1) fulfilled the diagnostic criteria for CKD (disease course > 3months); (2) underwent renal biopsy, (3) a prior 2D-SWE evaluation preceding the renal biopsy, and (4) obtained informed written consent.
Who cannot join
- (1) the presence of multiple renal cysts, calculi, hydronephrosis, or masses that could potentially interfere with the analysis conducted through 2D-SWE: (2) unsuccessful 2D-SWE measurements ;(3) biopsy specimens deemed inadequate due to insufficient length (less than 10 mm) or fewer than 10 glomeruli, and (4) incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ultrasound, Peking University Third Hospital
Beijing, Beiing, 100191
About this study
Official title: A Prospective, Single-Center Study: Evaluation of Chronic Kidney Disease Severity Using Ultrasonic Viscoelastic Parameters Combined With Clinical Indicators-With Histopathological Results as Gold Standard
The goal of this observational study is to learn about the role of ultrasonic viscoelastic parameters in the assessing the severity of chronic kidney disease. The main question it aims to answer is:
The accuracy of ultrasonic viscoelastic parameters in evaluating the degree of renal fibrosis and inflammation.
- Conditions
- Chronic Kidney Disease(CKD)
- Keywords
- chronic kidney disease, sonoelastogrphy, fibrosis, inflammation
- Medical subject headings
- Renal Insufficiency, Chronic, Fibrosis, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
renal fibrosis degree
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start24 Oct 2023
- Primary completion25 Mar 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease(CKD)Studies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ligang Cui, Dr, Principal investigator, Department of Ultrasound, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961162
- Sponsor's protocol ID
- M2023736
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng L, Lu M, Lee JM, Niu H, Fu Y, Yao Y, Tang W, Jiang J, Ma J, Cui L. The accuracy of ultrasound viscoelastic imaging in evaluating renal fibrosis and interstitial inflammation of chronic kidney disease. BMC Nephrol. 2026 Jan 30;27(1):140. doi: 10.1186/s12882-026-04762-y.
PubMed 41618226
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center Study: Evaluation of Chronic Kidney Disease Severity Using Ultrasonic Viscoelastic Parameters Combined With Clinical Indicators-With Histopathological Results as Gold Standard
- ClinicalTrials.gov ID
- NCT06961162
- Acronym / sponsor ID
- M2023736
- Conditions
- Chronic Kidney Disease(CKD)
- Keywords
- chronic kidney disease, sonoelastogrphy, fibrosis, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 7 May 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 goal of this observational study is to learn about the role of ultrasonic viscoelastic parameters in the assessing the severity of chronic kidney disease. The main question it aims to answer is:
The accuracy of ultrasonic viscoelastic parameters in evaluating the degree of renal fibrosis and inflammation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CKD patients who underwent renal biopsy at Peking University Third Hospital based on clinical requirements
Key inclusion criteria (1 listed)
- (1) fulfilled the diagnostic criteria for CKD (disease course > 3months); (2) underwent renal biopsy, (3) a prior 2D-SWE evaluation preceding the renal biopsy, and (4) obtained informed written consent.
Key exclusion criteria (1 listed)
- (1) the presence of multiple renal cysts, calculi, hydronephrosis, or masses that could potentially interfere with the analysis conducted through 2D-SWE: (2) unsuccessful 2D-SWE measurements ;(3) biopsy specimens deemed inadequate due to insufficient length (less than 10 mm) or fewer than 10 glomeruli, and (4) incomplete clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
renal fibrosis degree
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Derived from this study: PubMed 41618226Zeng L, Lu M, Lee JM, Niu H, Fu Y, Yao Y, Tang W, Jiang J, Ma J, Cui L. The accuracy of ultrasound viscoelastic imaging in evaluating renal fibrosis and interstitial inflammation of chronic kidney disease. BMC Nephrol. 2026 Jan 30;27(1):140. doi: 10.1186/s12882-026-04762-y.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ligang Cui, Dr principal investigator
Department of Ultrasound, Peking University Third Hospital
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 Chronic Kidney Disease(CKD), run by Peking University Third Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal fibrosis degree (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06961162, which also lists 1 linked publication.
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 7 May 2025.