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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Change in Glomerular Filtration Rate Estimated by Serum Creatinine (eGFR-EPI Cr)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
NEFRONIX Treatment
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.
干预措施: Ultrasound Stimulation (NEFRONIX G-01) (Device)
结局指标
主要结局
Change in Glomerular Filtration Rate Estimated by Serum Creatinine (eGFR-EPI Cr)
时间窗: 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.
次要结局
- 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)
- Change From Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) Concentration(Baseline to after 4 weeks of application of the investigational medical device)
- Change From Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) Concentration(Baseline to 12 weeks after application of the investigational medical device)
- Change From Baseline in Renal Resistive Index Assessed by Doppler Ultrasonography(Baseline to after 4 weeks of application of the investigational medical device)
- Change From Baseline in Renal Resistive Index Assessed by Doppler Ultrasonography(Baseline to 12 weeks after application of the investigational medical device)
- Change From Baseline in Serum Neutrophil Gelatinase-Associated Lipocalin (NGAL) Concentration(Baseline to after 4 weeks of application of the investigational medical device)
- Change From Baseline in Serum Neutrophil Gelatinase-Associated Lipocalin (NGAL) Concentration(Baseline to 12 weeks after application of the investigational medical device)
- Change in Renal Function Assessed by Tc-99m DTPA Renal Scintigraphy(Baseline to after 4 weeks of application of the investigational medical device)
- Change in Renal Function Assessed by Tc-99m DTPA Renal Scintigraphy(Baseline to 12 weeks after application of the investigational medical device)