Contrast-induced NephropathyLOTUSNCT04877847
Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury
A study testing Low-frequency therapeutic ultrasound (LOTUS) and LOTUS System with Ultrasound Disabled in people with Contrast-induced Nephropathy and Chronic Kidney Diseases, run by Sonogenix at 4 sites in United States.
Trial summary
Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-induced Nephropathy, Chronic Kidney Diseases
- What is being tested?
- Low-frequency therapeutic ultrasound (LOTUS) and LOTUS System with Ultrasound Disabled
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Sep 2021to 23 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is greater than or equal to 18 years
- Baseline renal dysfunction defined as one of the following:
- eGFR greater than 30
- eGFR 30-45, with or without risk factors for AKI defined as diabetes mellitus, congestive heart failure, proteinuria (defined as albuminuria greater than 300mg/day).
- eGFR 45-60, with at least one risk factor for AKI defined as diabetes mellitus, congestive heart failure, proteinuria (defined as albuminuria greater than 300mg/day).
- Participant is presenting for a planned percutaneous coronary intervention (PCI)
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- Participant scheduled to undergo cardiac catheterization including coronary arteriography that is anticipated to require at least 100 ml of iso-osmolar or low- osmolar contrast, and that is anticipated to include single-vessel stent implantation that does not include chronic total occlusion.
- Participant had not been hospitalized or treated for a change in renal function within 30 days of enrollment.
- Participant has provided written informed consent.
- Participant is willing to comply with study follow-up requirements.
Who cannot join
- Participant is anuric or currently undergoing renal replacement therapy.
- Participant is currently taking oral nitrates.
- Participant is undergoing a procedure requiring selective cannulation and injection of contrast into the renal arteries.
- Participant presented with ST-segment elevation myocardial infarction.
- Participant has a metal implant in the hip or lumbar spine.
- Participant received or is anticipated to receive additional intravenous or intraarterial contrast from 7 days prior to cardiac catheterization to 4 days after cardiac catheterization.
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- Addition, discontinuation, or dose change of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, diuretic, trimethoprim, non-steroidal anti-inflammatory drugs, cimetidine, or metoclopramide with 7 days prior to cardiac catheterization.
- Participant has a known allergy to contrast medium that cannot be adequately pre-medicated.
- Participant has new-onset heart failure with New York Heart Association (NYHA) classification of III or IV within 30 days prior to the index procedure.
- Recent stroke within 90 days prior to the index procedure.
- Participant has known or suspected active infection at the time of the index procedure.
- Participant is pregnant and/or breast-feeding or intends to become pregnant during the time of the study.
- Participant is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.
- Participant is known to be incarcerated, mentally incompetent, and/or alcohol or drug abuser.
- Participant is participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or subject is planning to participate in such studies prior to the completion of this study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Henry Ford Hopsital
Detroit, Michigan, 48202
McLaren Northern Michigan
Petoskey, Michigan, 49770
University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, 15213
UT Health San Antonio
San Antonio, Texas, 78229
About this study
Official title: Low Frequency Therapeutic Ultrasound System Pivotal Clinical Trial
Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure.
Read the detailed description
This is a multi-center, randomized, controlled clinical trial designed to assess the safety and performance of the Sonogenix RENOBOOST as an adjunctive therapy for maintaining renal function after contrast exposure. The trial will enroll up to 234 subjects not taking oral nitrates and at high-risk of developing PC-AKI undergoing coronary arteriography for a planned percutaneous coronary intervention in up to 10 clinical sites in the US and up to 3 clinical sites outside the US.
All subjects will be pre- treated with 0.9 percent NaCl at 3 ml/kg/h 1 hour before and 1 ml/kg/h during and 6 hours post procedure. Participants will be randomized in a 2:1 fashion to either active adjunctive therapy with the Sonogenix RENOBOOST or sham control.
Subjects will have clinical follow-up examination 30 days post index procedure.
- Being tested
- Low-frequency therapeutic ultrasound (LOTUS), LOTUS System with Ultrasound Disabled
- Keywords
- coronary arteriography, nitric oxide
- 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 ultrasound (LOTUS)Device
Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on per normal operating instructions.
LOTUS System with Ultrasound DisabledDevice
Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on and set to Control Setting.
| Study group | Role | What they receive |
|---|---|---|
| Low-Frequency Therapeutic Ultrasound | Experimental | LOTUS system will be operated per operated per normal instructions Receives: Device: Low-frequency therapeutic ultrasound (LOTUS) |
| Sham Control | Sham comparator | LOTUS system will be set to Control setting Receives: Device: LOTUS System with Ultrasound Disabled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
Incidence of acute kidney injury (AKI) defined as a greater than 0.3 mg/dl increase in serum creatinine (SCr)
Measured: 48 hours
Primary Safety Endpoint
Composite of all Adverse Events (AE) including RENOBOOST (device) related adverse events, and major adverse events (MAE)
Measured: 30 days
Secondary outcomes (11)
Incidence of Post Contrast Acute Kidney Injury
defined as greater than or equal to 0.3 mg/dl or greater than or equal to 25 percent rise in SCr
Measured: at 72 hours post-contrast exposure or need for renal replacement therapy (RRT)
Incidence of Post Contrast Acute Kidney Injury
defined as greater than or equal to 0.5 mg/dl or greater than or equal to 25 percent rise in SCr
Measured: at 72 hours post-contrast exposure or need for renal replacement therapy (RRT)
Incidence of contrast-induced nephropathy
defined as greater than or equal to 0.3 mg/dl or greater than or equal to 25 percent rise in SCr
Measured: within 96 hours post-contrast exposure or need for RRT
Occurrence of (stage 1, 2, or 3) acute kidney injury (AKI)
defined as greater than or equal to 2-fold rise in SCr, increase in SCr to greater than or equal to 4.0 mg/dl, or initiation of RRT
Measured: within 30 days after index procedure
Incidence of Post Contrast Acute Kidney Injury
defined as greater than or equal to 0.3 mg/dl or greater than or equal to 25 percent rise in SCr
Measured: within 96 hours post-contrast exposure or need for RRT
Occurrence of (stage 1, 2, or 3) acute kidney injury (AKI)
defined as Stage 1 - Serum Creatinine 1.5-1.9 times baseline or greater than or equal to 0.3 mg/dL increase, Stage 2 - Serum Creatinine 2-2.9 times baseline, Stage 3 - Serum Creatinine 3 times baseline or Increase in serum creatinine to greater than or equal to 4 mg/dL or Initiation of renal replacement therapy
Measured: within 96 hours of index procedure
Maximum percent-change
Maximum percent-change in SCr
Measured: within 96 hours after contrast exposure
Absolute and percent-change in estimated glomerular filtration rate (eGFR)
as calculated using the Modification of Diet in Renal Disease Study Group (MDRD)
Measured: from baseline within 96 hours after contrast exposure.
Total urine output
defined as the amount of urine collected in cc/hour.
Measured: through baseline procedure
Hospitalization
Hospital length of stay
Measured: following the baseline procedure through discharge from the hospital up to 30 days
Intensive Care
Intensive care unit length of stay
Measured: following the baseline procedure through discharge from the Intensive Care Unit up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start24 Sep 2021
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Why it stopped: Low Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-induced NephropathyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of up to 234 participants will be randomized 2:1
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonogenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877847
- Sponsor's protocol ID
- CP-001
- Acronym
- LOTUS
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Frequency Therapeutic Ultrasound System Pivotal Clinical Trial
- ClinicalTrials.gov ID
- NCT04877847
- Acronym / sponsor ID
- LOTUS / CP-001
- Keywords
- coronary arteriography, nitric oxide
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- SonogenixIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 7 May 2021 (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.
Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure.
Detailed description
This is a multi-center, randomized, controlled clinical trial designed to assess the safety and performance of the Sonogenix RENOBOOST as an adjunctive therapy for maintaining renal function after contrast exposure. The trial will enroll up to 234 subjects not taking oral nitrates and at high-risk of developing PC-AKI undergoing coronary arteriography for a planned percutaneous coronary intervention in up to 10 clinical sites in the US and up to 3 clinical sites outside the US.
All subjects will be pre- treated with 0.9 percent NaCl at 3 ml/kg/h 1 hour before and 1 ml/kg/h during and 6 hours post procedure. Participants will be randomized in a 2:1 fashion to either active adjunctive therapy with the Sonogenix RENOBOOST or sham control.
Subjects will have clinical follow-up examination 30 days post index procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A total of up to 234 participants will be randomized 2:1
| Arm | Type | Receives |
|---|---|---|
| Low-Frequency Therapeutic Ultrasound | Experimental | Device: Low-frequency therapeutic ultrasound (LOTUS)LOTUS system will be operated per operated per normal instructions |
| Sham Control | Sham comparator | Device: LOTUS System with Ultrasound DisabledLOTUS system will be set to Control setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant is greater than or equal to 18 years
- Baseline renal dysfunction defined as one of the following:
- Participant is presenting for a planned percutaneous coronary intervention (PCI)
- Participant scheduled to undergo cardiac catheterization including coronary arteriography that is anticipated to require at least 100 ml of iso-osmolar or low- osmolar contrast, and that is anticipated to include single-vessel stent implantation that does not include chronic total occlusion.
- Participant had not been hospitalized or treated for a change in renal function within 30 days of enrollment.
Key exclusion criteria (15 listed)
- Participant is anuric or currently undergoing renal replacement therapy.
- Participant is currently taking oral nitrates.
- Participant is undergoing a procedure requiring selective cannulation and injection of contrast into the renal arteries.
- Participant presented with ST-segment elevation myocardial infarction.
- Participant has a metal implant in the hip or lumbar spine.
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 ultrasound (LOTUS)Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on per normal operating instructions. | Device | Low-Frequency Therapeutic Ultrasound |
| LOTUS System with Ultrasound DisabledParticipants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on and set to Control Setting. | Device | Sham Control |
Primary outcome
Primary Efficacy Endpoint
Time frame: 48 hours
Incidence of acute kidney injury (AKI) defined as a greater than 0.3 mg/dl increase in serum creatinine (SCr)
Primary Safety Endpoint
Time frame: 30 days
Composite of all Adverse Events (AE) including RENOBOOST (device) related adverse events, and major adverse events (MAE)
11 secondary outcomes
Incidence of Post Contrast Acute Kidney Injury
Time frame: at 72 hours post-contrast exposure or need for renal replacement therapy (RRT)
Incidence of Post Contrast Acute Kidney Injury
Time frame: at 72 hours post-contrast exposure or need for renal replacement therapy (RRT)
Incidence of contrast-induced nephropathy
Time frame: within 96 hours post-contrast exposure or need for RRT
Occurrence of (stage 1, 2, or 3) acute kidney injury (AKI)
Time frame: within 30 days after index procedure
Incidence of Post Contrast Acute Kidney Injury
Time frame: within 96 hours post-contrast exposure or need for RRT
Occurrence of (stage 1, 2, or 3) acute kidney injury (AKI)
Time frame: within 96 hours of index procedure
Maximum percent-change
Time frame: within 96 hours after contrast exposure
Absolute and percent-change in estimated glomerular filtration rate (eGFR)
Time frame: from baseline within 96 hours after contrast exposure.
Total urine output
Time frame: through baseline procedure
Hospitalization
Time frame: following the baseline procedure through discharge from the hospital up to 30 days
Intensive Care
Time frame: following the baseline procedure through discharge from the Intensive Care Unit up to 30 days
Results and safety
The study was stopped early (reason given: Low Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Contrast-induced Nephropathy
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
Not yet recruitingObservational study
An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
Not yet recruitingObservational study
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 (LOTUS) and LOTUS System with Ultrasound Disabled in people with Contrast-induced Nephropathy and Chronic Kidney Diseases, run by Sonogenix at 4 sites 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 10 inclusion and 15 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Low Recruitment). Results are not available in the source record.
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?
Primary Efficacy Endpoint (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 12 Apr 2023.