Chronic Kidney DiseaseNCT02026544
Effect of Low Frequency Ultrasound on Kidney Function
A study testing Low Frequency Therapeutic Ultrasound in people with Chronic Kidney Disease, run by Sonogenix at 1 site in United States.
Trial summary
The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Low Frequency Therapeutic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2014to 6 Oct 2014
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be >/= 18 years of age
- Must have documented Stage 3 to Stage 4 (eGFR 15 - 59) chronic kidney disease
- Females with childbearing potential must not be pregnant at the time of study
- Subject must provide written informed consent
Who cannot join
- Unable or unwilling to cooperate with study procedures
- Currently enrolled in another clinical study for which the follow-up period is not complete
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Radiology and Biomedical Imaging, UCSF
San Francisco, California, 94107
About this study
Official title: Evaluation of the Effect of Low Frequency Therapeutic Ultrasound (LOTUS) on Kidney Function in Chronic Kidney Disease
The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.
- Conditions
- Chronic Kidney Disease
- Being tested
- Low Frequency Therapeutic Ultrasound
- Keywords
- low frequency ultrasound, glomerular filtration rate
- 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.
Low Frequency Therapeutic UltrasoundDevice
29 kHz (kilohertz) low frequency therapeutic ultrasound delivered transcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Low Frequency Therapeutic Ultrasound | Experimental | Low Frequency Therapeutic Ultrasound (LOTUS) applied transcutaneously Receives: Device: Low Frequency Therapeutic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular Filtration Rate (GFR)
Absolute change in glomerular filtration rate, GFR, measured by Tc-99m DTPA (diethylenetriamine pentaacetic acid) imaging (Gates Method) in the treated kidney(s) from baseline to during LOTUS
Measured: Baseline and 15 minutes after start of Intervention
Secondary outcomes (2)
Percent change in GFR
Percent change in GFR in the treated kidney(s) from baseline to during LOTUS.
Measured: Baseline and 15 minutes after start of Intervention
Blood Pressure
Blood pressure is measured at baseline, during LOTUS intervention, and immediately after LOTUS intervention
Measured: Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study start28 Jan 2014
- Primary completion6 Oct 2014
- Study completion6 Oct 2014
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 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonogenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall A Hawkins, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026544
- Sponsor's protocol ID
- PRO-0001
- Status last verified
- Apr 2021
- First submitted
- 19 Dec 2013
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Dae MW, Liu KD, Solomon RJ, Gao DW, Stillson CA. Effect of Low-Frequency Therapeutic Ultrasound on Induction of Nitric Oxide in CKD: Potential to Prevent Acute Kidney Injury. Kidney Dis (Basel). 2020 Nov;6(6):453-460. doi: 10.1159/000509819. Epub 2020 Aug 21.
PubMed 33313066
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Low Frequency Therapeutic Ultrasound (LOTUS) on Kidney Function in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02026544
- Acronym / sponsor ID
- PRO-0001
- Conditions
- Chronic Kidney Disease
- Keywords
- low frequency ultrasound, glomerular filtration rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SonogenixIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2014 (actual)
- Primary completion
- 6 Oct 2014 (actual)
- Study completion
- 6 Oct 2014 (actual)
- First posted
- 3 Jan 2014 (estimated)
- 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 purpose of this study is to find out what effect, if any, Low Frequency Therapeutic Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Frequency Therapeutic Ultrasound | Experimental | Device: Low Frequency Therapeutic UltrasoundLow Frequency Therapeutic Ultrasound (LOTUS) applied transcutaneously |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be >/= 18 years of age
- Must have documented Stage 3 to Stage 4 (eGFR 15 - 59) chronic kidney disease
- Females with childbearing potential must not be pregnant at the time of study
- Subject must provide written informed consent
Key exclusion criteria (2 listed)
- Unable or unwilling to cooperate with study procedures
- Currently enrolled in another clinical study for which the follow-up period is not complete
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 |
|---|---|---|
| Low Frequency Therapeutic Ultrasound29 kHz (kilohertz) low frequency therapeutic ultrasound delivered transcutaneously | Device | Low Frequency Therapeutic Ultrasound |
Primary outcome
Glomerular Filtration Rate (GFR)
Time frame: Baseline and 15 minutes after start of Intervention
Absolute change in glomerular filtration rate, GFR, measured by Tc-99m DTPA (diethylenetriamine pentaacetic acid) imaging (Gates Method) in the treated kidney(s) from baseline to during LOTUS
2 secondary outcomes
Percent change in GFR
Time frame: Baseline and 15 minutes after start of Intervention
Blood Pressure
Time frame: Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention
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 22 Apr 2021.
- Results publication: PubMed 33313066Dae MW, Liu KD, Solomon RJ, Gao DW, Stillson CA. Effect of Low-Frequency Therapeutic Ultrasound on Induction of Nitric Oxide in CKD: Potential to Prevent Acute Kidney Injury. Kidney Dis (Basel). 2020 Nov;6(6):453-460. doi: 10.1159/000509819. Epub 2020 Aug 21.
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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.
Randall A Hawkins, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Frequency Therapeutic Ultrasound in people with Chronic Kidney Disease, run by Sonogenix 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 4 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: finished, as of the sponsor's last update on 22 Apr 2021. 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?
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?
Glomerular Filtration Rate (GFR) (time frame: Baseline and 15 minutes after start of Intervention). 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 NCT02026544, 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 22 Apr 2021.