Nephrospec Switzerland

NCT06194591 | Recruiting DMC

• 1 other identifier: 2023-D0075
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Kidney Diseases; Hypertension

Keywords

CKD; Chronic Kidney Disease; Hypertension; Li-ESWT; Low-Intensity Extracorporeal Shock Wave Therapy

Outcome Measures

Primary Outcomes (1)

• Systolic 24-hour ambulatory blood pressure (ABPM)

  Assess the Systolic 24-hour ambulatory blood pressure depending on the particpant's arm affiliation

  Baseline to 12-weeks (-1/+3weeks) Follow-up post last treatment.

Secondary Outcomes (10)

• attended Automatic Office Blood Pressure

  baseline to 4 weeks (+3 weeks), 24 weeks (±3 weeks) and 48 weeks (±3 weeks) post last treatment

• unattended Automatic Office Blood Pressure

  from baseline to 4 weeks (+3 weeks), 24 weeks (±3 weeks) and 48 weeks (±3 weeks) post last treatment

• Number, dose or number of medications to maintain blood pressure control

  baseline to 24 weeks (±3 weeks), and 48 weeks (±3 weeks) post last treatment

• Serum creatinine levels / eGFR - calculated by CKD - EPI

  baseline to 4 weeks (+3 weeks), 12 weeks (-1/+3 weeks), 24 weeks (±3 weeks), and 48 weeks (±3 weeks) post last treatment.

• Albumin/creatinine ratio (ACR)

  baseline to 4 weeks (+3 weeks), 12 weeks (-1/+3 weeks), 24 weeks (±3 weeks), and 48 weeks (±3 weeks) post last treatment.

Study Arms (3)

Stage A - Active treatment

ACTIVE COMPARATOR

The medical device NephrospecTM is used to administer 6 treatments of Low-intensity extracorporeal shockwave therapy (Li-ESWT) to the kidneys during 3 weeks.

Device: NephrospecTM, low-intensity extracorporal shockwave therapy device

Stage A - Sham treatment

SHAM COMPARATOR

The sham group will undergo the same treatment schedule, but with an applicator with an internal barrier to prevent shockwaves to pass through to the patient.

Device: Sham-Device

Stage B - Open label active treatment

ACTIVE COMPARATOR

Patients that were in the placebo group of stage A and do not exhibit a significant improvement in one of the main parameters will be eligible to enter stage B where they are treated with the active device in an open-label fashion.

Device: NephrospecTM, low-intensity extracorporal shockwave therapy device

Interventions

NephrospecTM, low-intensity extracorporal shockwave therapy device 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.

Stage A - Active treatment; Stage B - Open label active treatment

Sham-Device DEVICE

The sham device is the NephrospecTM applicator with an internal barrier to prevent shockwaves to pass through to the patient.

Stage A - Sham treatment

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years to 82 years.
• Patient is diagnosed with Hypertension, i.e. home,office and/or 24h systolic blood pressure ≥135 mmHg (as per ISH guidelines, 2020), currently on stable (over 60 days) medical therapy as prescribed by a physician, of none, one, or more antihypertensive medication classes. Patients will be considered stable if no relevant medication change for over 60 days or for 30 days if there were no previous changes 90 days before the current change.
• Patients diagnosed with moderate to severe chronic renal failure (eGFR 20-70 mL/min/1.73m2) who are currently on stable medical therapy as prescribed by a physician.
• Patients with eGFR between 60-90 ml/min/1.73m2 and albuminuria \>=30mg/mmol in spot urine or \>=300mg/day in 24h urine collection
• Patient is able and willing to comply with the required follow-up schedule.
• Patient is capable of giving an informed consent.

You may not qualify if:

• Hypertension: Individual's systolic BP is over 180mmHg when receiving stable medical medication regimen as prescribed by a physician, of none, one, or more antihypertensive medication classes at maximally tolerated dose. Hypertension secondary to an identifiable and treatable cause, other than Renal artery stenosis or CKD, or is prescribed a medication that may raise BP.
• History of previous renal artery stent. Stent or other intervention involving renal arteries including but not limited to renal denervation procedures.
• Kidney conditions non compatible with the study: Patient has an eGFR \<20 ml/min/1.73m², is on Dialysis or has had a kidney transplant performed. Active pyelonephritis. History of or current kidney stones. Patients with polycystic kidney disease or a known complicated renal cyst (Bosniak III or higher).
• Symptomatic patients (Macrohematuria) with a decrease of over 2 grams in Hb.
• Hemoglobin (Hb) ≤ 9 grams per deciliter (blood).
• Coagulation issues: Bleeding tendency resulting from hematologic disease. Subjects having INR \> 2.5 and PT, PTT and platelet count which deviates from the clinical laboratory normal reference range.
• Diseases non compatible with the study: Recent (less than 6 months) history of myocardial infarction, PCI, stroke or hospitalization for HFrEF (heart failure with reduced ejection fraction). Individual has type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c \> 10%).
• Active Cancer - primary tumor or metastatic, such as liver, renal, testicular, abdominal tumor or local tumor at treatment area..
• Treatment non compatible with the study: Patients that have been treated with immunosuppression in the last 3 months. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. No change in dosing of RAS inhibitors in the month prior to the procedure is required.
• Technical impossibility to participate: Local infection of the skin at the area to be in contact with the applicator.
• Known allergy to Sonovue® contrast product (hypersensibility to sulfur hexyfluoride or another component).
• No other contraindication to SonoVue, ie. patients with right-to-left shunts, severe pulmonary hypertension (pulmonary arterial pressure \> 90 mm Hg), uncontrolled systemic hypertension and in adult patients with respiratory distress syndrome (ARDS).
• Contraindication to undergo MR-imaging such as the presence of a pacemaker or other implanted metallic device or severe claustrophobia.
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject/ Unable to obtain consent
• Known or suspected non-compliance, drug or alcohol abuse

Sponsors & Collaborators

• Menno Pruijm: lead

Study Sites (1)

Department of Nephrology, Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Menno Pruijm, Dr

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Menno Pruijm, Dr

CONTACT

+41 (0)21 314 13 58; menno.pruijm@chuv.ch

Wendy Brito

CONTACT

Wendy.Brito@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A sham device is used. The sham device is visually identical to the NephrospecTM device but disposes of a metal bar that prevents the shockwaves to be transmitted to the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pr.

Model Details: The medical device used to administer Low-intensity extracorporeal shockwave therapy (Li-ESWT) is the NephrospecTM device from Curespec (manufacutred by Medispec). This device is CE-marked, has been used in previous studies, and will be used according to its instructions of use.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 8, 2024
• Study Start: February 19, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CH (1)