Back to resultsEffect of Low Frequency Ultrasound on Kidney Function
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Frequency Therapeutic Ultrasound
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Kidney Disease focused on measuring low frequency ultrasound, glomerular filtration rate
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unable or unwilling to cooperate with study procedures
- Currently enrolled in another clinical study for which the follow-up period is not complete
Sites / Locations
- Department of Radiology and Biomedical Imaging, UCSF
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low Frequency Therapeutic Ultrasound
Arm Description
Low Frequency Therapeutic Ultrasound (LOTUS) applied transcutaneously
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Percent change in GFR
Percent change in GFR in the treated kidney(s) from baseline to during LOTUS.
Blood Pressure
Blood pressure is measured at baseline, during LOTUS intervention, and immediately after LOTUS intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02026544
Brief Title
Effect of Low Frequency Ultrasound on Kidney Function
Official Title
Evaluation of the Effect of Low Frequency Therapeutic Ultrasound (LOTUS) on Kidney Function in Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 28, 2014 (Actual)
Primary Completion Date
October 6, 2014 (Actual)
Study Completion Date
October 6, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonogenix
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
low frequency ultrasound, glomerular filtration rate
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Frequency Therapeutic Ultrasound
Arm Type
Experimental
Arm Description
Low Frequency Therapeutic Ultrasound (LOTUS) applied transcutaneously
Intervention Type
Device
Intervention Name(s)
Low Frequency Therapeutic Ultrasound
Intervention Description
29 kHz (kilohertz) low frequency therapeutic ultrasound delivered transcutaneously
Primary Outcome Measure Information:
Title
Glomerular Filtration Rate (GFR)
Description
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
Time Frame
Baseline and 15 minutes after start of Intervention
Secondary Outcome Measure Information:
Title
Percent change in GFR
Description
Percent change in GFR in the treated kidney(s) from baseline to during LOTUS.
Time Frame
Baseline and 15 minutes after start of Intervention
Title
Blood Pressure
Description
Blood pressure is measured at baseline, during LOTUS intervention, and immediately after LOTUS intervention
Time Frame
Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention
Other Pre-specified Outcome Measures:
Title
Cutaneous Injury
Description
Occurrence of cutaneous injury, such as erythema, blistering or rash occuring below the site of transducer placement
Time Frame
5 minutes after LOTUS intervention
Title
Heart rate
Description
Heart rate will be measured at baseline, during LOTUS intervention, and immediately after LOTUS intervention has ended.
Time Frame
Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Unable or unwilling to cooperate with study procedures
Currently enrolled in another clinical study for which the follow-up period is not complete
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall A Hawkins, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiology and Biomedical Imaging, UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33313066
Citation
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.
Results Reference
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Effect of Low Frequency Ultrasound on Kidney Function
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