NCT07339098Not yet recruiting
Efficacy and Safety of the Ultrasound Stimulation Device NEFRONIX in Patients With Chronic Kidney Disease
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)
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 5 Jan 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Anasonic
- Diseases
- Chronic kidney disease
- NCT number
- NCT07339098
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Feb 2026 to the primary completion date, 1 Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have received a kidney transplant.
- Participants with uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg despite treatment with two or more antihypertensive medications).
- Participants receiving immunosuppressive therapy.
Other illness
- Participants with heart failure.
- Participants who have undergone reperfusion therapy for cardiovascular disease within the past year.
- Participants with acute or chronic urinary tract infection.
- Participants with anatomical kidney abnormalities (e.g., solitary kidney, horseshoe kidney, polycystic kidney disease) as determined by the investigator.
- Participants with a history of severe illness, such as cancer or tuberculosis.
Lab values
- Participants with platelet or coagulation disorders, including those receiving antithrombotic therapy.
- 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.
Other
- Participants currently enrolled in another clinical study with an ongoing follow-up period.
- Participants with polycystic kidneys.
- Participants with urinary tract obstruction.
- 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 liver dysfunction.
- Participants with body mass index (BMI) \>35 kg/m² or body weight \<40 kg.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.