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Zapping kidney nerves may tame tough blood pressure

NCT ID NCT04264403

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device that uses ultrasound to calm overactive nerves in the kidneys, which can drive high blood pressure. Researchers enrolled 44 people with stage 3 chronic kidney disease and uncontrolled hypertension. Half received the real procedure, half a sham, to see if it safely lowers 24-hour blood pressure readings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
renal denervation device (Paradise® System) that uses ultrasound energy to calm kidney nerves
What this could lead to
If it works, this could offer a new way to control blood pressure in people with chronic kidney disease without adding more pills.
What could go wrong
This was a small, early feasibility study with only 44 participants, so results may not apply to everyone. The procedure carries risks like blood vessel damage or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

44 people

The number who actually took part.

Started

Jan 2020

Finished

Apr 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * CKD stage 3 (eGFR 30-59 ml/min/1.73m² \[according to the currently used estimation formulas: MDRD, CKD-EPI\]) with diabetic or non-diabetic nephropathy * Uncontrolled hypertension with 1-5 drug classes (renin angiotensin system \[RAS\] blockade is mandatory, unless intolerance to RAS blockers has been documented) and systolic office (attended) BP ≥140 mmHg confirmed by 24-h ambulatory BP systolic ≥130 mmHg * Patient is adhering to a stable drug regimen including RAS blockade without changes for a minimum of 4 weeks. * Individual is ≥ 18 years of age, both genders are included. Exclusion Criteria: * Anatomically significant renal artery abnormality in either renal artery which in the eyes of the interventionalist would interfere with safe catheter Placement * Other cause of Hypertension that can be treated by Intervention/surgery (e.g. hemodynamically relevant renal artery stenosis, functional adrenal adenoma) * Prior renal denervation procedure * Office (attended) BP ≥ 180 mmHg systolic and/or ≥ 110 mmHg diastolic * 24-h ambulatory BP ≥ 160 mmHg systolic * Anatomic or functional solitary kidney, kidney transplantation * Lack of capturing serum creatinine levels in the past * Secondary hypertension other than obstructive sleep apnea * Type 1 diabetes mellitus * Nephrotic syndrome * Contraindication to magnetic resonance imaging (MRI) * Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 months of the screening visit * Acute episode of renal disease requiring uptitration of any immunosuppressive drug regimen within the last 3 months * Subject is pregnant, nursing, or intends to become pregnant * Enrollment in another interventional research protocol. * Any condition that, at the discretion of the investigator, would preclude participation in the study (e.g. non-adherence)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Clinical Research Center Nuremberg, Department of Nephrology, University Hospital Erlangen

    Nuremberg, Germany

  • Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg

    Erlangen, 91054, Germany

  • Heinrich Heine University Düsseldorf, Nephrologie, Germany

    Düsseldorf, 40225, Germany

  • Klinik für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Saarland University Hospital, Saarland University

    Homburg, 66421, Germany

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