NCT05460169Active, not recruiting
Renal Denervation in ADPKD- RDN-ADPKD Study
Effect of Renal Denervation in Hypertensive Patients With Autosomal Dominant Polycystic Kidney Disease
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
RDN-ADPKD is a prospective, randomized (1:1, central randomization), single-center, hypothesis-generating, feasibility study. The purpose of the RDN-ADPKD study is to demonstrate efficacy and document safety of renal denervation (RDN) with the Paradise System in hypertensive patients with ADPKD.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 15 Jun 2022
- Start date
- 14 Jun 2022
- Primary completion date
- Mar 2028
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- NCT number
- NCT05460169
What you commit to
- Study type: Interventional
- Planned participants: 44
- From 14 Jun 2022 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior renal denervation procedure
Other illness
- 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
- Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 months of the screening visit
- Any condition that, at the discretion of the investigator, would preclude participation in the study (e.g. non-adherence)
Lab values
- 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))
Other
- Anatomically significant renal artery abnormality in either renal artery which in the eyes of the interventionalist would interfere with safe catheter placement
- Office (attended) BP ≥180 mmHg systolic and/or ≥110 mmHg diastolic
- 24-h ambulatory BP ≥160 mmHg systolic
- Proteinuria (\>3g/g Kreatinin)
- Contraindication to MRI
- Subject is pregnant, nursing, or intends to become pregnant
- Enrollment in another interventional research protocol
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital FAU Erlangen-Nürnberg Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.