Could zapping kidney nerves tame tough blood pressure in polycystic kidney disease?
NCT ID NCT05460169
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests a device that uses ultrasound to burn nerves around the kidney arteries, aiming to lower blood pressure in people with autosomal dominant polycystic kidney disease (ADPKD) whose blood pressure remains high despite medication. 44 participants will be randomly assigned to get the procedure right away or after a delay. The main goal is to see if the treatment safely reduces 24-hour blood pressure at 3 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Paradise® Renal Denervation System (ultrasound catheter to ablate kidney nerves)
- What this could lead to
- If it works, this could offer a new way to control blood pressure in people with polycystic kidney disease, potentially slowing kidney damage.
- What could go wrong
- This is a small, early feasibility study with only 44 participants. The blood pressure drop may be modest, and long-term safety or effectiveness is not yet proven.
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
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patients with ADPKD * Systolic office (attended) BP ≥130 mmHg or diastolic office (attended) BP ≥80 mmHg confirmed by 24-h ambulatory BP systolic ≥125 mmHg or diastolic ≥75 mmHg despite treatment with 1-4 drug classes (RAS blockade is mandatory, unless intolerance to RAS blockers has been documented) The rationale of these inclusion criteria reflect the November 2021 updated knowledge of RDN according to international consensus reports, in particular in face of conducting clinic studies and randomized controlled trials and does not necessarily reflect the current application of RDN in clinical practice). Moreover, the most recent updated KDIGO guidelines recommend a target office BP \< 120 mmHg in patients with chronic kidney disease.1. * Patient is adhering to a stable drug regimen without changes for a minimum of 4 weeks * Individual is ≥ 18 years of age, both genders are included Exclusion Criteria: * eGFR \< 40ml/min/1.73m² (according to the currently used estimation formulas: MDRD (Modification of Diet in Renal Disease), CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)) * Anatomically significant renal artery abnormality in either renal artery which in the eyes of the interventionalist would interfere with safe catheter placement * Prior renal denervation procedure * Office (attended) BP ≥180 mmHg systolic and/or ≥110 mmHg diastolic * 24-h ambulatory BP ≥160 mmHg systolic * Other cause of hypertension that can be treated by intervention/surgery (e.g. hemodynamically relevant renal artery stenosis, functional adrenal adenoma) * Type 1 diabetes mellitus * Proteinuria (\>3g/g Kreatinin) * Contraindication to MRI * Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 months of the screening visit * 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
-
University Hospital FAU Erlangen-Nürnberg
Erlangen, 91054, Germany
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Other studies related to the condition(s) this trial covers.
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