Efficacy and Safety of the Ultrasound Stimulation Device NEFRONIX in Patients With Chronic Kidney Disease

NCT07339098 | Not Yet Recruiting

• 2 other identifiers: Cenovia1866
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline to 12 weeks after application of the investigational medical device

• Change in Glomerular Filtration Rate Estimated by Cystatin C (eGFR-EPI CysC)

  Baseline to after 4 weeks of application of the investigational medical device

• Change in Glomerular Filtration Rate Estimated by Cystatin C (eGFR-EPI CysC)

  Baseline to 12 weeks after application of the investigational medical device

• Change From Baseline in Urinary Protein Excretion

  Baseline to after 4 weeks of application of the investigational medical device

• Change From Baseline in Urinary Protein Excretion

  Baseline to 12 weeks after application of the investigational medical device

Study Arms (1)

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.

Device: Ultrasound Stimulation (NEFRONIX G-01)

Interventions

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.

NEFRONIX Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Anasonic: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

SungKyung Lee

CONTACT

82+10-9877-8173; sklee@deepsonbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 14, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share