NCT06961162

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 29, 2025

Last Update Submit

May 6, 2025

Conditions

Chronic Kidney Disease(CKD)

Keywords

chronic kidney diseasesonoelastogrphyfibrosisinflammation

Outcome Measures

Primary Outcomes (1)

  • renal fibrosis degree

    one week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CKD patients who underwent renal biopsy at Peking University Third Hospital based on clinical requirements

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ultrasound, Peking University Third Hospital

Beijing, Beiing, 100191, China

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicFibrosisInflammation

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ligang Cui, Dr

    Department of Ultrasound, Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 7, 2025

Study Start

October 24, 2023

Primary Completion

March 25, 2024

Study Completion

June 3, 2024

Last Updated

May 7, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)