Chronic Kidney DiseaseNCT07339098
Efficacy and Safety of the Ultrasound Stimulation Device NEFRONIX in Patients With Chronic Kidney Disease
A study testing Ultrasound Stimulation (NEFRONIX G-01) in people with Chronic Kidney Disease, run by Anasonic.
Trial summary
This study is a prospective, multicenter, single-arm, open-label, non-randomized exploratory clinical trial designed to evaluate the safety and potential efficacy of an ultrasound stimulation device (NEFRONIX G-01) in patients with chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Ultrasound Stimulation (NEFRONIX G-01)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Dec 2027
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have received sufficient explanation of the study and have voluntarily provided written informed consent.
- Male and female adults aged 18 to 65 years at the time of consent.
- Participants with chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) between 20 and 60 mL/min/1.73 m².
- Participants who agree to use and maintain appropriate contraception throughout the study period.
Who cannot join
- Participants currently enrolled in another clinical study with an ongoing follow-up period.
- Participants with heart failure.
- Participants who have undergone reperfusion therapy for cardiovascular disease within the past year.
- Participants with platelet or coagulation disorders, including those receiving antithrombotic therapy.
- Participants with acute or chronic urinary tract infection.
- Participants with polycystic kidneys.
Show all 20Show fewer
- Participants with anatomical kidney abnormalities (e.g., solitary kidney, horseshoe kidney, polycystic kidney disease) as determined by the investigator.
- Participants with urinary tract obstruction.
- Participants who have received a kidney transplant.
- Participants with kidney or urinary tract stones.
- Participants who have experienced acute kidney injury or changes in CKD stage within the past 3 months.
- Participants with serum albumin <3.0 g/dL and either 24-hour proteinuria ≥3.0 g/day or random urine protein/creatinine ratio ≥3.0 mg/mg.
- Participants with uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg despite treatment with two or more antihypertensive medications).
- Participants with liver dysfunction.
- Participants receiving immunosuppressive therapy.
- Participants with body mass index (BMI) >35 kg/m² or body weight <40 kg.
- Participants with a history of severe illness, such as cancer or tuberculosis.
- Participants with contact dermatitis or other significant skin sensitivities.
- Participants with fever ≥40°C (104°F) measured via tympanic temperature.
- Participants deemed unsuitable for participation in the study by the investigator for any other reason.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Single-arm, Open-label, Non-randomized Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Glomerular Filtration Rate (GFR-EPI) Using NEFRONIX in Patients With Chronic Kidney Disease (CKD)
This study is a prospective, multicenter, single-arm, open-label, non-randomized exploratory clinical trial designed to evaluate the safety and potential efficacy of an ultrasound stimulation device (NEFRONIX G-01) in patients with chronic kidney disease (CKD). Baseline functional assessments will be performed prior to intervention. Participants will receive ultrasound stimulation applied to the kidneys three times per week for four weeks according to the study protocol. Clinical evaluations will be conducted at baseline, at the end of treatment, and 12 weeks after completion of treatment. Renal function will be assessed using changes in estimated glomerular filtration rate based on serum creatinine (CKD-EPI eGFR Cr) and cystatin C (CKD-EPI eGFR CysC). Additional assessments will include imaging studies (Tc-99m DTPA renal scintigraphy and renal ultrasonography), urinalysis for proteinuria, inflammatory markers (high-sensitivity C-reactive protein), and renal injury biomarkers (neutrophil gelatinase-associated lipocalin).
- Conditions
- Chronic Kidney Disease
- Being tested
- Ultrasound Stimulation (NEFRONIX G-01)
- 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.
Ultrasound Stimulation (NEFRONIX G-01)Device
Ultrasound stimulation will be delivered to the renal area using the NEFRONIX G-01 device. The intervention will be administered three times per week for four weeks in accordance with the study protocol. Standard clinical management for chronic kidney disease will be continued during the study period.
| Study group | Role | What they receive |
|---|---|---|
| NEFRONIX Treatment | Experimental | Participants in this arm will receive ultrasound stimulation using the NEFRONIX G-01 device applied to the kidneys three times per week for four weeks, in accordance with the study protocol. Standard clinical care for chronic kidney disease will be maintained throughout the study period. Receives: Device: Ultrasound Stimulation (NEFRONIX G-01) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glomerular Filtration Rate Estimated by Serum Creatinine (eGFR-EPI Cr)
The primary outcome is the change in glomerular filtration rate estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on serum creatinine (eGFR-EPI Cr) from baseline to after 4 weeks of application of the investigational medical device.
Measured: Baseline to after 4 weeks of application of the investigational medical device
Secondary outcomes (13)
Change in Glomerular Filtration Rate Estimated by Serum Creatinine (eGFR-EPI Cr)
Measured: Baseline to 12 weeks after application of the investigational medical device
Change in Glomerular Filtration Rate Estimated by Cystatin C (eGFR-EPI CysC)
Measured: Baseline to after 4 weeks of application of the investigational medical device
Change in Glomerular Filtration Rate Estimated by Cystatin C (eGFR-EPI CysC)
Measured: Baseline to 12 weeks after application of the investigational medical device
Change From Baseline in Urinary Protein Excretion
Measured: Baseline to after 4 weeks of application of the investigational medical device
Change From Baseline in Urinary Protein Excretion
Measured: Baseline to 12 weeks after application of the investigational medical device
Change From Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) Concentration
Measured: Baseline to after 4 weeks of application of the investigational medical device
Change From Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) Concentration
Measured: Baseline to 12 weeks after application of the investigational medical device
Change From Baseline in Renal Resistive Index Assessed by Doppler Ultrasonography
Measured: Baseline to after 4 weeks of application of the investigational medical device
Change From Baseline in Renal Resistive Index Assessed by Doppler Ultrasonography
Measured: Baseline to 12 weeks after application of the investigational medical device
Change From Baseline in Serum Neutrophil Gelatinase-Associated Lipocalin (NGAL) Concentration
Measured: Baseline to after 4 weeks of application of the investigational medical device
Change From Baseline in Serum Neutrophil Gelatinase-Associated Lipocalin (NGAL) Concentration
Measured: Baseline to 12 weeks after application of the investigational medical device
Change in Renal Function Assessed by Tc-99m DTPA Renal Scintigraphy
Measured: Baseline to after 4 weeks of application of the investigational medical device
Change in Renal Function Assessed by Tc-99m DTPA Renal Scintigraphy
Measured: Baseline to 12 weeks after application of the investigational medical device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anasonic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339098
- Sponsor's protocol ID
- Cenovia
- Other IDs
- 1866
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm, Open-label, Non-randomized Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Glomerular Filtration Rate (GFR-EPI) Using NEFRONIX in Patients With Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT07339098
- Acronym / sponsor ID
- Cenovia
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AnasonicIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 14 Jan 2026 (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.
This study is a prospective, multicenter, single-arm, open-label, non-randomized exploratory clinical trial designed to evaluate the safety and potential efficacy of an ultrasound stimulation device (NEFRONIX G-01) in patients with chronic kidney disease (CKD). Baseline functional assessments will be performed prior to intervention. Participants will receive ultrasound stimulation applied to the kidneys three times per week for four weeks according to the study protocol. Clinical evaluations will be conducted at baseline, at the end of treatment, and 12 weeks after completion of treatment. Renal function will be assessed using changes in estimated glomerular filtration rate based on serum creatinine (CKD-EPI eGFR Cr) and cystatin C (CKD-EPI eGFR CysC). Additional assessments will include imaging studies (Tc-99m DTPA renal scintigraphy and renal ultrasonography), urinalysis for proteinuria, inflammatory markers (high-sensitivity C-reactive protein), and renal injury biomarkers (neutrophil gelatinase-associated lipocalin).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEFRONIX Treatment | Experimental | Device: Ultrasound Stimulation (NEFRONIX G-01)Participants in this arm will receive ultrasound stimulation using the NEFRONIX G-01 device applied to the kidneys three times per week for four weeks, in accordance with the study protocol. Standard clinical care for chronic kidney disease will be maintained throughout the study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who have received sufficient explanation of the study and have voluntarily provided written informed consent.
- Male and female adults aged 18 to 65 years at the time of consent.
- Participants with chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) between 20 and 60 mL/min/1.73 m².
- Participants who agree to use and maintain appropriate contraception throughout the study period.
Key exclusion criteria (20 listed)
- Participants currently enrolled in another clinical study with an ongoing follow-up period.
- Participants with heart failure.
- Participants who have undergone reperfusion therapy for cardiovascular disease within the past year.
- Participants with platelet or coagulation disorders, including those receiving antithrombotic therapy.
- Participants with acute or chronic urinary tract infection.
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 |
|---|---|---|
| Ultrasound Stimulation (NEFRONIX G-01)Ultrasound stimulation will be delivered to the renal area using the NEFRONIX G-01 device. The intervention will be administered three times per week for four weeks in accordance with the study protocol. Standard clinical management for chronic kidney disease will be continued during the study period. | Device | NEFRONIX Treatment |
Primary outcome
Change in Glomerular Filtration Rate Estimated by Serum Creatinine (eGFR-EPI Cr)
Time frame: Baseline to after 4 weeks of application of the investigational medical device
The primary outcome is the change in glomerular filtration rate estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on serum creatinine (eGFR-EPI Cr) from baseline to after 4 weeks of application of the investigational medical device.
13 secondary outcomes
Change in Glomerular Filtration Rate Estimated by Serum Creatinine (eGFR-EPI Cr)
Time frame: Baseline to 12 weeks after application of the investigational medical device
Change in Glomerular Filtration Rate Estimated by Cystatin C (eGFR-EPI CysC)
Time frame: Baseline to after 4 weeks of application of the investigational medical device
Change in Glomerular Filtration Rate Estimated by Cystatin C (eGFR-EPI CysC)
Time frame: Baseline to 12 weeks after application of the investigational medical device
Change From Baseline in Urinary Protein Excretion
Time frame: Baseline to after 4 weeks of application of the investigational medical device
Change From Baseline in Urinary Protein Excretion
Time frame: Baseline to 12 weeks after application of the investigational medical device
Change From Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) Concentration
Time frame: Baseline to after 4 weeks of application of the investigational medical device
Change From Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) Concentration
Time frame: Baseline to 12 weeks after application of the investigational medical device
Change From Baseline in Renal Resistive Index Assessed by Doppler Ultrasonography
Time frame: Baseline to after 4 weeks of application of the investigational medical device
Change From Baseline in Renal Resistive Index Assessed by Doppler Ultrasonography
Time frame: Baseline to 12 weeks after application of the investigational medical device
Change From Baseline in Serum Neutrophil Gelatinase-Associated Lipocalin (NGAL) Concentration
Time frame: Baseline to after 4 weeks of application of the investigational medical device
Change From Baseline in Serum Neutrophil Gelatinase-Associated Lipocalin (NGAL) Concentration
Time frame: Baseline to 12 weeks after application of the investigational medical device
Change in Renal Function Assessed by Tc-99m DTPA Renal Scintigraphy
Time frame: Baseline to after 4 weeks of application of the investigational medical device
Change in Renal Function Assessed by Tc-99m DTPA Renal Scintigraphy
Time frame: Baseline to 12 weeks after application of the investigational medical device
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 15 Jan 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Stimulation (NEFRONIX G-01) in people with Chronic Kidney Disease, run by Anasonic.
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 20 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: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 SungKyung Lee (82+10-9877-8173, sklee@deepsonbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glomerular Filtration Rate Estimated by Serum Creatinine (eGFR-EPI Cr) (time frame: Baseline to after 4 weeks of application of the investigational medical device). 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 15 Jan 2026.