Acute Kidney DiseaseNCT02830438
Shear Wave Elastography in Native Kidney Disease
A study testing Shear wave elastography in people with Acute Kidney Disease and Chronic Kidney Disease, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
In this proposal, the aim is to examine shear wave elastography (SWE) measurements in diseased native kidneys and correlate them with grades of fibrosis using histological samples. The overall goals of the proposed study are addressed by the following specific aim. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Disease, Chronic Kidney Disease
- What is being tested?
- Shear wave elastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 10 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- All patients over 18 years of age who are referred for a native kidney biopsy.
Who cannot join
- BMI > 35
- Patients with polycystic kidney disease, renal cell carcinoma, hydronephrosis or renal stones.
- Patients who develop severe post biopsy complications (infection, significant bleeding requiring transfusion or intervention)
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
About this study
Official title: Shear Wave Elastography in Native Kidney Disease: a Pilot Study
In this proposal, the aim is to examine shear wave elastography (SWE) measurements in diseased native kidneys and correlate them with grades of fibrosis using histological samples.
The overall goals of the proposed study are addressed by the following specific aim.
Specific aim: To determine whether differences exist in elasticity measurements between native kidneys with and without fibrosis.
Hypothesis: Kidneys with higher grades of fibrosis will demonstrate higher measures of tissue elasticity and stiffness compared to kidneys with zero fibrosis.
Read the detailed description
The proposed project is a prospective cross-sectional study correlating native kidney shear wave elastography (SWE) measurements with histology. Briefly, patients referred for a native kidney biopsy will undergo SWE and the shear wave velocity (SWV) will be correlated with degree of fibrosis determined by a pathologist.
A list of patients who recently underwent a native kidney biopsy will be obtained from the pathology department on a weekly basis. Patients will then be contacted about participating in the study and consented during a follow up visit with their nephrologist.
After their biopsies, patients will be scheduled to come for a renal ultrasound and SWE. SWE examination will be conducted using an ultrasound machine equipped with a Philips Epiq ARFI Shear wave ElastPQ C1-5 mHz transducer. Shear wave velocity will be obtained and an estimate of tissue elasticity (Young's modulus) will be calculated. All measurements will be performed by one of two qualified radiology physicians who will be blinded to the clinical and pathological data. We will allow a period of 90 days to obtain the images after the biopsy; otherwise the patient is no longer eligible to participate.
The primary outcome measure of this study is to determine whether tissue elasticity determined by SWE can assess kidney fibrosis. Linear regression analysis will be performed to describe the relation of the extent of fibrosis and parenchymal stiffness.
- Conditions
- Acute Kidney Disease, Chronic Kidney Disease
- Being tested
- Shear wave elastography
- Keywords
- kidney disease, fibrosis, ultrasound, elastography
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear wave elastographyDevice
Ultrasound technique of the kidneys to assess wave elastography.
| Study group | Role | What they receive |
|---|---|---|
| Shear wave elastography group | Experimental | Patients referred for kidney biopsy will then undergo shear wave elastography measurements. Receives: Device: Shear wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear Wave Velocity of Kidney Parenchyma
The shear wave velocity of the kidneys will be determined using the elastography ultrasound machine. This will enable us to calculate the tissue elasticity using a standard formula. Shear wave velocity is measured in meters per second, at a range of 0-5 m/s with the highest number reporting hard consistency (fibrosis - worse outcome).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion10 Jun 2018
- Study completion10 Jun 2018
Why it stopped: Not enough participants recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Naranjo-Tovar, MD, Albert Einstein Healthcare Network
- Investigators
- Mario Naranjo-Tovar, MD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830438
- Sponsor's protocol ID
- 4837
- Other IDs
- 8574
- Status last verified
- May 2020
- First submitted
- 7 Jul 2016
- Last updated
- 5 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hu Q, Wang XY, He HG, Wei HM, Kang LK, Qin GC. Acoustic radiation force impulse imaging for non-invasive assessment of renal histopathology in chronic kidney disease. PLoS One. 2014 Dec 29;9(12):e115051. doi: 10.1371/journal.pone.0115051. eCollection 2014.
PubMed 25546304Samir AE, Allegretti AS, Zhu Q, Dhyani M, Anvari A, Sullivan DA, Trottier CA, Dougherty S, Williams WW, Babitt JL, Wenger J, Thadhani RI, Lin HY. Shear wave elastography in chronic kidney disease: a pilot experience in native kidneys. BMC Nephrol. 2015 Jul 31;16:119. doi: 10.1186/s12882-015-0120-7.
PubMed 26227484Lee J, Oh YT, Joo DJ, Ma BG, Lee AL, Lee JG, Song SH, Kim SU, Jung DC, Chung YE, Kim YS. Acoustic Radiation Force Impulse Measurement in Renal Transplantation: A Prospective, Longitudinal Study With Protocol Biopsies. Medicine (Baltimore). 2015 Sep;94(39):e1590. doi: 10.1097/MD.0000000000001590.
PubMed 26426636
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear Wave Elastography in Native Kidney Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT02830438
- Acronym / sponsor ID
- 4837
- Conditions
- Acute Kidney Disease, Chronic Kidney Disease
- Keywords
- kidney disease, fibrosis, ultrasound, elastography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough participants recruited
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 10 Jun 2018 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 5 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this proposal, the aim is to examine shear wave elastography (SWE) measurements in diseased native kidneys and correlate them with grades of fibrosis using histological samples.
The overall goals of the proposed study are addressed by the following specific aim.
Specific aim: To determine whether differences exist in elasticity measurements between native kidneys with and without fibrosis.
Hypothesis: Kidneys with higher grades of fibrosis will demonstrate higher measures of tissue elasticity and stiffness compared to kidneys with zero fibrosis.
Detailed description
The proposed project is a prospective cross-sectional study correlating native kidney shear wave elastography (SWE) measurements with histology. Briefly, patients referred for a native kidney biopsy will undergo SWE and the shear wave velocity (SWV) will be correlated with degree of fibrosis determined by a pathologist.
A list of patients who recently underwent a native kidney biopsy will be obtained from the pathology department on a weekly basis. Patients will then be contacted about participating in the study and consented during a follow up visit with their nephrologist.
After their biopsies, patients will be scheduled to come for a renal ultrasound and SWE. SWE examination will be conducted using an ultrasound machine equipped with a Philips Epiq ARFI Shear wave ElastPQ C1-5 mHz transducer. Shear wave velocity will be obtained and an estimate of tissue elasticity (Young's modulus) will be calculated. All measurements will be performed by one of two qualified radiology physicians who will be blinded to the clinical and pathological data. We will allow a period of 90 days to obtain the images after the biopsy; otherwise the patient is no longer eligible to participate.
The primary outcome measure of this study is to determine whether tissue elasticity determined by SWE can assess kidney fibrosis. Linear regression analysis will be performed to describe the relation of the extent of fibrosis and parenchymal stiffness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shear wave elastography group | Experimental | Device: Shear wave elastographyPatients referred for kidney biopsy will then undergo shear wave elastography measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over 18 years of age who are referred for a native kidney biopsy.
Key exclusion criteria (4 listed)
- BMI > 35
- Patients with polycystic kidney disease, renal cell carcinoma, hydronephrosis or renal stones.
- Patients who develop severe post biopsy complications (infection, significant bleeding requiring transfusion or intervention)
- Pregnant patients.
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 elastographyUltrasound technique of the kidneys to assess wave elastography. | Device | Shear wave elastography group |
Primary outcome
Shear Wave Velocity of Kidney Parenchyma
Time frame: 6 months
The shear wave velocity of the kidneys will be determined using the elastography ultrasound machine. This will enable us to calculate the tissue elasticity using a standard formula. Shear wave velocity is measured in meters per second, at a range of 0-5 m/s with the highest number reporting hard consistency (fibrosis - worse outcome).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25546304Hu Q, Wang XY, He HG, Wei HM, Kang LK, Qin GC. Acoustic radiation force impulse imaging for non-invasive assessment of renal histopathology in chronic kidney disease. PLoS One. 2014 Dec 29;9(12):e115051. doi: 10.1371/journal.pone.0115051. eCollection 2014.
- Results publication: PubMed 26227484Samir AE, Allegretti AS, Zhu Q, Dhyani M, Anvari A, Sullivan DA, Trottier CA, Dougherty S, Williams WW, Babitt JL, Wenger J, Thadhani RI, Lin HY. Shear wave elastography in chronic kidney disease: a pilot experience in native kidneys. BMC Nephrol. 2015 Jul 31;16:119. doi: 10.1186/s12882-015-0120-7.
- Results publication: PubMed 26426636Lee J, Oh YT, Joo DJ, Ma BG, Lee AL, Lee JG, Song SH, Kim SU, Jung DC, Chung YE, Kim YS. Acoustic Radiation Force Impulse Measurement in Renal Transplantation: A Prospective, Longitudinal Study With Protocol Biopsies. Medicine (Baltimore). 2015 Sep;94(39):e1590. doi: 10.1097/MD.0000000000001590.
- 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.
Mario Naranjo-Tovar, MD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shear wave elastography in people with Acute Kidney Disease and Chronic Kidney Disease, run by Albert Einstein Healthcare Network at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 5 Jun 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Shear Wave Velocity of Kidney Parenchyma (time frame: 6 months). 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 NCT02830438, which also lists 3 linked publications.
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 5 Jun 2020.