Chronic Kidney DiseasesNCT06194591
Nephrospec Switzerland
A study testing NephrospecTM, low-intensity extracorporal shockwave therapy device in people with Chronic Kidney Diseases and Hypertension, run by Menno Pruijm at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension
- What is being tested?
- NephrospecTM, low-intensity extracorporal shockwave therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Feb 2024to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wendy Brito contact
Switzerland1 site, 1 recruiting
- Recruiting
Department of Nephrology, Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
Menno Pruijm, Dr, 0041795565946, menno.pruijm@chuv.ch
About this study
Official title: 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
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).
Read the 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
- Being tested
- NephrospecTM, low-intensity extracorporal shockwave therapy device, Sham-Device
- Keywords
- CKD, Chronic Kidney Disease, Hypertension, Li-ESWT, Low-Intensity Extracorporeal Shock Wave Therapy
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NephrospecTM, low-intensity extracorporal shockwave therapy deviceDevice
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.
Sham-DeviceDevice
The sham device is the NephrospecTM applicator with an internal barrier to prevent shockwaves to pass through to the patient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: NephrospecTM, low-intensity extracorporal shockwave therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic 24-hour ambulatory blood pressure (ABPM)
Assess the Systolic 24-hour ambulatory blood pressure depending on the particpant's arm affiliation
Measured: Baseline to 12-weeks (-1/+3weeks) Follow-up post last treatment.
Secondary outcomes (10)
attended Automatic Office Blood Pressure
Assess the attended Automatic Office Blood Pressure depending on the particpant's arm
Measured: baseline to 4 weeks (+3 weeks), 24 weeks (±3 weeks) and 48 weeks (±3 weeks) post last treatment
unattended Automatic Office Blood Pressure
Assess the unattended Automatic Office Blood Pressure depending on the particpant's arm
Measured: 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
Assess the number, dose or number of medications to maintain blood pressure control depending on the particpant's arm
Measured: baseline to 24 weeks (±3 weeks), and 48 weeks (±3 weeks) post last treatment
Serum creatinine levels / eGFR - calculated by CKD - EPI
Assess the serum creatinine levels / eGFR (calculated by CKD - EPI) depending on the particpant's arm
Measured: 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)
Assess the albumin/creatinine ratio (ACR) depending on the particpant's arm
Measured: baseline to 4 weeks (+3 weeks), 12 weeks (-1/+3 weeks), 24 weeks (±3 weeks), and 48 weeks (±3 weeks) post last treatment.
CEUS-assessed Perfusion Index (PI)
Assess the CEUS-assessed Perfusion Index (PI) depending on the particpant's arm
Measured: baseline to 12 weeks (±3 weeks)
MRI-assessed oxygenation (R2*), fibrosis (ADC) and Phase-contrast
Assess the MRI-assessed oxygenation (R2*), fibrosis (ADC) and Phase-contrast depending on the particpant's arm
Measured: baseline to 12 weeks (±3 weeks)
Plasma renin activity
Assess the plasma renin activity depending on the particpant's arm
Measured: baseline to 12 weeks (±3 weeks)
Plasma aldosterone levels
Assess the plasma aldosterone levels depending on the particpant's arm
Measured: baseline to 12 weeks (±3 weeks)
Cystatin C levels
Assess the cystatin C levels depending on the particpant's arm
Measured: baseline to 12 weeks (±3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start19 Feb 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menno Pruijm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Menno Pruijm, Centre Hospitalier Universitaire Vaudois
- Investigators
- Menno Pruijm, Dr, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194591
- Sponsor's protocol ID
- 2023-D0075
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06194591
- Acronym / sponsor ID
- 2023-D0075
- Conditions
- Chronic Kidney Diseases, Hypertension
- Keywords
- CKD, Chronic Kidney Disease, Hypertension, Li-ESWT, Low-Intensity Extracorporeal Shock Wave Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Menno PruijmUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stage A - Active treatment | Active comparator | Device: NephrospecTM, low-intensity extracorporal shockwave therapy deviceThe medical device NephrospecTM is used to administer 6 treatments of Low-intensity extracorporeal shockwave therapy (Li-ESWT) to the kidneys during 3 weeks. |
| Stage A - Sham treatment | Sham comparator | Device: Sham-DeviceThe 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. |
| Stage B - Open label active treatment | Active comparator | Device: NephrospecTM, low-intensity extracorporal shockwave therapy devicePatients 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. |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NephrospecTM, low-intensity extracorporal shockwave therapy devicePatients 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 | Stage A - Active treatment, Stage B - Open label active treatment |
| Sham-DeviceThe sham device is the NephrospecTM applicator with an internal barrier to prevent shockwaves to pass through to the patient. | Device | Stage A - Sham treatment |
Primary outcome
Systolic 24-hour ambulatory blood pressure (ABPM)
Time frame: Baseline to 12-weeks (-1/+3weeks) Follow-up post last treatment.
Assess the Systolic 24-hour ambulatory blood pressure depending on the particpant's arm affiliation
10 secondary outcomes
attended Automatic Office Blood Pressure
Time frame: baseline to 4 weeks (+3 weeks), 24 weeks (±3 weeks) and 48 weeks (±3 weeks) post last treatment
unattended Automatic Office Blood Pressure
Time frame: 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
Time frame: baseline to 24 weeks (±3 weeks), and 48 weeks (±3 weeks) post last treatment
Serum creatinine levels / eGFR - calculated by CKD - EPI
Time frame: 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)
Time frame: baseline to 4 weeks (+3 weeks), 12 weeks (-1/+3 weeks), 24 weeks (±3 weeks), and 48 weeks (±3 weeks) post last treatment.
CEUS-assessed Perfusion Index (PI)
Time frame: baseline to 12 weeks (±3 weeks)
MRI-assessed oxygenation (R2*), fibrosis (ADC) and Phase-contrast
Time frame: baseline to 12 weeks (±3 weeks)
Plasma renin activity
Time frame: baseline to 12 weeks (±3 weeks)
Plasma aldosterone levels
Time frame: baseline to 12 weeks (±3 weeks)
Cystatin C levels
Time frame: baseline to 12 weeks (±3 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendy Brito contact
Menno Pruijm, Dr principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NephrospecTM, low-intensity extracorporal shockwave therapy device in people with Chronic Kidney Diseases and Hypertension, run by Menno Pruijm at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Menno Pruijm, Dr (+41 (0)21 314 13 58, menno.pruijm@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic 24-hour ambulatory blood pressure (ABPM) (time frame: Baseline to 12-weeks (-1/+3weeks) Follow-up post last treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.