ElastographyCKD-SWENCT04404114
Shear Wave Elastography in Differentiating Acute or Chronic Kidney Disease
An observational study of Elastography and Chronic Kidney Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Chronic kidney disease is a common global public health issue and its prevalence increased year by year. Early diagnosis and intervention can prevent further complications and comorbidities of long-term dialysis, cardiovascular events and mortality as well as improve the patients' life quality. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Elastography, Chronic Kidney Diseases
- What is being tested?
- Shear wave elastography to distinguish AKI from normal kidney, Shear wave elastography to distinguish AKI from CKD and Shear wave elastography to distinguish CKD from normal kidney
- How many people
- 800 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2020to 31 Dec 2026
- How long will I take part?
- 2 Weeks
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 400 patients with normal kidney function and 400 patients with abnormal kidney function
Who may be able to join
- The patients older than 20 years old who needed to receive renal sonography in emergency department of National Taiwan University Hospital.
Who cannot join
- The patients who didn't obtain agreement.
- The patients who can't cooperate or follow the directions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Wan-Ching Lien, MD., PhD, +886-2-23123456 ext. 65637, wanchinglien@ntu.edu.tw
Jia-Yu Chen, MD., qwe96963@gmail.com
About this study
Chronic kidney disease is a common global public health issue and its prevalence increased year by year. Early diagnosis and intervention can prevent further complications and comorbidities of long-term dialysis, cardiovascular events and mortality as well as improve the patients' life quality. To differentiate acute from chronic kidney disease was crucial especially in the setting of crowded and high-risk emergency department. To diagnose acute or chronic kidney disease, physicians usually use blood sample test combined with image studies such as conventional sonography, CT and MRI. However, there was lots of limited factors. The patients may have no previous visit records, poor renal function to receive contrast medium, or critical clinical condition to undergo time-wasting exam. Although the conventional renal sonography is accessible and inexpensive, the judgement is subjective and provide little clinical information. Recent researches of shear wave elastography in evaluating renal parenchymal stiffness showed some correlation with nephropathy. In our study, aiming to facilitating clinical implication, the investigators will use swear-wave elastography combined with conventional renal sonography to benefit patients in diagnosis of acute or chronic kidney disease.
Read the detailed description
This is a case-control study. The investigators obtained data from participants who were older than 20 years old and received renal sonography examination in the emergency department of National Taiwan University Hospital. The investigators examined the participants' kidneys by recording the kidney size, cortical thickness, possible lesions and elasticity by shear-wave elastography. These data combined with the participants' medical history and renal function revealed by blood examination will be analyzed. This study was designed to determine the correlation between renal cortical elasticity and chronic kidney disease.
- Conditions
- Elastography, Chronic Kidney Diseases
- Being tested
- Shear wave elastography to distinguish AKI from normal kidney, Shear wave elastography to distinguish AKI from CKD, Shear wave elastography to distinguish CKD from normal kidney
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear wave elastography to distinguish AKI from normal kidneyDiagnostic test
Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
Shear wave elastography to distinguish AKI from CKDDiagnostic test
Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
Shear wave elastography to distinguish CKD from normal kidneyDiagnostic test
Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Normal renal function Receives: Diagnostic Test: Shear wave elastography to distinguish AKI from normal kidney | |
| Acute kidney injury in normal kidney | Acute kidney injury in normal kidney Receives: Diagnostic Test: Shear wave elastography to distinguish AKI from normal kidney | |
| Acute kidney injury in chronic kidney disease | Acute kidney injury in chronic kidney disease Receives: Diagnostic Test: Shear wave elastography to distinguish AKI from CKD | |
| Chronic kidney disease | Chronic kidney disease Receives: Diagnostic Test: Shear wave elastography to distinguish CKD from normal kidney |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the correlation of kPa ratio and renal function in chronic renal disease
The analysis will be conducted to determine the correlation between kPa ratio measured by elastography and renal function in patients with chronic renal disease
Measured: change in renal function after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElastographyStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- 800 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404114
- Sponsor's protocol ID
- 202001091RINC
- Acronym
- CKD-SWE
- Status last verified
- Oct 2025
- First submitted
- 28 Apr 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear Wave Elastography in Differentiating Acute or Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04404114
- Acronym / sponsor ID
- CKD-SWE / 202001091RINC
- Conditions
- Elastography, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 May 2020 (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.
Chronic kidney disease is a common global public health issue and its prevalence increased year by year. Early diagnosis and intervention can prevent further complications and comorbidities of long-term dialysis, cardiovascular events and mortality as well as improve the patients' life quality. To differentiate acute from chronic kidney disease was crucial especially in the setting of crowded and high-risk emergency department. To diagnose acute or chronic kidney disease, physicians usually use blood sample test combined with image studies such as conventional sonography, CT and MRI. However, there was lots of limited factors. The patients may have no previous visit records, poor renal function to receive contrast medium, or critical clinical condition to undergo time-wasting exam. Although the conventional renal sonography is accessible and inexpensive, the judgement is subjective and provide little clinical information. Recent researches of shear wave elastography in evaluating renal parenchymal stiffness showed some correlation with nephropathy. In our study, aiming to facilitating clinical implication, the investigators will use swear-wave elastography combined with conventional renal sonography to benefit patients in diagnosis of acute or chronic kidney disease.
Detailed description
This is a case-control study. The investigators obtained data from participants who were older than 20 years old and received renal sonography examination in the emergency department of National Taiwan University Hospital. The investigators examined the participants' kidneys by recording the kidney size, cortical thickness, possible lesions and elasticity by shear-wave elastography. These data combined with the participants' medical history and renal function revealed by blood examination will be analyzed. This study was designed to determine the correlation between renal cortical elasticity and chronic kidney disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | – | Diagnostic Test: Shear wave elastography to distinguish AKI from normal kidneyNormal renal function |
| Acute kidney injury in normal kidney | – | Diagnostic Test: Shear wave elastography to distinguish AKI from normal kidneyAcute kidney injury in normal kidney |
| Acute kidney injury in chronic kidney disease | – | Diagnostic Test: Shear wave elastography to distinguish AKI from CKDAcute kidney injury in chronic kidney disease |
| Chronic kidney disease | – | Diagnostic Test: Shear wave elastography to distinguish CKD from normal kidneyChronic kidney disease |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 400 patients with normal kidney function and 400 patients with abnormal kidney function
Key inclusion criteria (1 listed)
- The patients older than 20 years old who needed to receive renal sonography in emergency department of National Taiwan University Hospital.
Key exclusion criteria (2 listed)
- The patients who didn't obtain agreement.
- The patients who can't cooperate or follow the directions
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 |
|---|---|---|
| Shear wave elastography to distinguish AKI from normal kidneyRecord the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography | Diagnostic test | Acute kidney injury in normal kidney, Normal renal function |
| Shear wave elastography to distinguish AKI from CKDRecord the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography | Diagnostic test | Acute kidney injury in chronic kidney disease |
| Shear wave elastography to distinguish CKD from normal kidneyRecord the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography | Diagnostic test | Chronic kidney disease |
Primary outcome
To determine the correlation of kPa ratio and renal function in chronic renal disease
Time frame: change in renal function after 2 weeks
The analysis will be conducted to determine the correlation between kPa ratio measured by elastography and renal function in patients with chronic renal disease
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 18 Nov 2025.
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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.
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 Elastography and Chronic Kidney Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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 18 Nov 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 Taiwan. 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 Wan C. Lien, A.P (+886 972651315, dtemer17@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the correlation of kPa ratio and renal function in chronic renal disease (time frame: change in renal function after 2 weeks). 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 18 Nov 2025.