NCT06194591

Nephrospec Switzerland

Low-intensity Extracorporeal Shockwave Therapy With the Nephrospec TM Device for the Treatment of Hypertension in Patients Diagnosed With Chronic Kidney Disease (CKD) : a Randomized, Double-blind Sham-controlled Monocentric Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Menno Pruijm · Academic / Other
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind sham-controlled monocentric trial. 30 patients that are diagnosed with hypertension and with moderate to severe chronic kidney disease are included in this trial. 20 of them are randomized into the active treatment arm, 10 into the sham arm. Low-intensity extracorporal shock wave (Li-ESWT) sessions (arm1) or sham sessions (arm2), will be administered with a dedicated probe within three consecutive weeks to the kidneys of patients.The study will add data to the effects of the shock wave treatment on blood pressure and will assess whether this treatment improves renal function, perfusion and oxygenation. The study includes a third arm (arm3) in which treatment sessions are administered to patients that were in the placebo group in the first phase of the study (arm2).

Detailed description

This is a randomized, double-blind sham-controlled monocentric trial. Adult patients that are diagnosed with hypertension (systolic blood pressure 135 - 180 mmHg), currently on stable (over 60 days) medical therapy and with moderate to severe chronic kidney disease (eGFR 20-70 mL/min/1.73m2) or with eGFR between 60-90 ml/min/1.73m 2 and albuminuria ≥30 mg/mmol in spot urine or ≥300 mg/day in 24h urine collection who are currently on stable (at least 60 days) medical therapy are included in this trial. 20 patients are randomized into the active treatment arm with the investigational medical device, 10 patients into the sham arm. Low-intensity extracorporal shock wave (Li-ESWT) sessions (arm1) with a dedicated probe (Nephrospec device) or sham sessions (arm2), within three consecutive weeks, will be applied to the kidneys of patients. Patients will be followed-up for 48 weeks after the treatment.The study includes a third arm (arm3) in which treatment sessions are administered to patients that were in the placebo group in the first phase of the study and for whom their condition did not improve (arm 2). Low-intensity extracorporeal shockwave therapy (Li-ESWT) is based on the classic technique of lithotripsy for the extracorporeal treatment of kidney stones but applied at much lower intensity (\~10%). Previous histological studies in animals have shown that Li-ESWT has favourable effects on kidney perfusion and oxygenation. In human studies that included patients with diabetic nephropathy, six to twelve sessions of Li-ESWT lead to long-term reduction of blood pressure and stabilization of renal function (eGFR). The medical device Nephrospec TM is CE-mark and used in the ambulatory setting to lower BP in patients with CKD. The device will be used according to the instructions and indications mentioned in the operator manual. The primary outcome of this trial is the change in systolic 24-hour ambulatory blood pressure (ABPM) from baseline to 12 weeks post treatment. Further important secondary ouctomes are automatic office blood pressure (AOBP), the change in number or dose of blood pressure medications, the change in eGFR and the change in albumine/creatinine ratio (ACR). Furthermore, the study will assess whether the treatment improves renal function, Contrast enhanced ultrasound (CEUS)-assessed perfusion index, as well as renal oxygenation and fibrosis (ADC) assessed by MRI.

Conditions

• Chronic Kidney Diseases
• Hypertension

Interventions

Type	Name	Description
DEVICE	NephrospecTM, low-intensity extracorporal shockwave therapy device	Patients will receive 6 Li-ESWT treatments with the NephrospecTM device over three consecutive weeks, with a minimal recess of 24 hours between treatments and a maximum of 3 sessions per week. Three hundred shockwaves will be applied by the PI or co-PI to each one of 8 pre-selected regions of each kidney, under ultrasound control, with the patient in the prone position. No local anaesthesia is needed. Total treatment time of one session is 30 minutes. The participant will remain under supervision for another 30 minutes and will be discharged hereafter.
DEVICE	Sham-Device	The sham device is the NephrospecTM applicator with an internal barrier to prevent shockwaves to pass through to the patient.

Timeline

• Start date: 2024-02-19
• Primary completion: 2028-09-30
• Completion: 2029-06-30
• First posted: 2024-01-08
• Last updated: 2026-01-23

Locations

1 site across 1 country: Switzerland