Nephrospec Switzerland

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Chronic Kidney Diseases, Hypertension

In brief

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).

Key facts

Study ID

NCT06194591

Run by

Menno Pruijm

People needed

30

Starts

2024-02-19

Expected to finish

2029-06-30

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older, up to 82. Sex: any. Healthy volunteers: not accepted.

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
• Individual works night shifts.
• Individual is pregnant, breast feeding or planning to become pregnant.
• Individual does not want to be informed in case of accidental finding related to individual's health discovered during imaging or other study-related exams.
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
• Previous enrolment into the current investigation,
• Enrolment of the PI, his/her family members, employees, and other dependent persons

Where it is running

• Department of Nephrology, Centre Hospitalier Universitaire Vaudois — Lausanne, Canton of Vaud, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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