NCT07339098

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Anasonic · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2026-01-14
• Last updated: 2026-01-15