Efficacy and Safety of the Ultrasound Stimulation Device NEFRONIX in Patients With Chronic Kidney… (NCT07339098) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of the Ultrasound Stimulation Device NEFRONIX in Patients With Chronic Kidney Disease
20 participantsStarted 2026-02-01
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 …
What they're measuring
1
Change in Glomerular Filtration Rate Estimated by Serum Creatinine (eGFR-EPI Cr)
Timeframe: Baseline to after 4 weeks of application of the investigational medical device