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Uncontrolled HypertensionRDN-ADPKDNCT05460169

Renal Denervation in ADPKD- RDN-ADPKD Study

A study testing Renal denervation in people with Uncontrolled Hypertension and Autosomal Dominant Polycystic Kidney Disease, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Renal denervation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteGermany
Study dates
14 Jun 2022to Mar 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital FAU Erlangen-Nürnberg

    Erlangen, 91054

Other trials in Germany

About this study

Official title: Effect of Renal Denervation in Hypertensive Patients With Autosomal Dominant Polycystic Kidney Disease

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.

Read the detailed description
  1. Introduction:Increased blood pressure (BP) is a common finding in patients with autosomal dominant polycystic kidney disease (ADPKD) which is one of the leading causes of end stage renal disease. Previously, it was shown that hypertensive patients with ADPKD have increased sympathetic nerve activity regardless of renal function. This was one of the pathogenetic mechanisms that leads to the progression of renal failure, even independent of BP. Recent clinical studies have indicated that invasive, catheter-based renal denervation (RDN) decreases sympathetic nerve activity. Up to date, only two single case reports have suggested a safe and effective procedure of RDN in an ADPKD patient with uncontrolled hypertension.
  2. Study purpose: The purpose of the RDN-ADPKD pilot study is to demonstrate efficacy and document safety of RDN with the Paradise System in hypertensive patients with ADPKD.
  3. Study design: RDN-ADPKD is a prospective, randomized (1:1, central randomization), single-center, hypothesis-generating, feasibility study. Patients are randomized into (immediate) I-RDN-group and (delayed) D-RDN-group, respectively. After 3 months, patients in the D-RDN-group will undergo RDN-procedure and will be followed for additional 36 months. Hence, study design allows several comparisons both of whole study group (at same time-point of follow-up) as well as between I-RDN-group and D-RDN-group.
  4. Patient population: 44 hypertensive patients with ADPKD are randomized with 22 patients allocated to the I-RDN-group and 22 patients to the D-RDN-group (receiving RDN after 3 months), respectively.
  5. Primary endpoint: The primary endpoint of this pilot study is the change in systolic 24-h ambulatory BP at 3 months post-procedure in the whole study group (irrespective whether treated immediate [I-RDN-group] or delayed [D-RDN-group]) compared to baseline.
  6. Visit and Follow-Up Schedule: The primary objective will be assessed at 13 weeks (3 months) post-procedure in both groups. Scheduled in-clinic follow-up (FU) visits will occur at least at 13 (3 months) and 26 (6 months) 52 (12 months), 78 weeks (18 months),104 weeks (24 months), 130 weeks (30 months) and 156 weeks (36 months) post procedure; however, scheduled Follow-Up visits at 3, 7,20 weeks, 78 weeks and 130 weeks post-procedure are possible as in-clinic FU visit as well as ambulant visit at the allocation centre(s) of the referring physician.
  7. Randomization: The subjects will be randomized to I-RDN group or D-RDN group at Visit 2.
  8. Medication Adherence: Adherence to drug therapy will be captured by interviewing patients, checking the patient's BP diary and by urinary toxicological analysis at baseline, 26 weeks, 52 weeks, 104 weeks and 156 weeks post-procedure visit.
  9. Safety Signals: A major combined safety endpoint is the incidence of any major adverse events (MAE) through the 36 months Follow-up.
  10. Escape Criteria: Enrolled subjects will be excluded:
  • if home BP increases to ≥160 systolic or ≥100 mmHg diastolic pre-randomization, confirmed by office (attended) BP ≥170/105 mmHg will be excluded
  • if office (attended) BP exceeds ≥170/105 mmHg pre-randomization, confirmed by 7-day average of home BP measurements ≥ 160/100 mmHg (excluding white coat effect) or confirmed by office (attended) BP ≥170/105 mmHg at another study visit.
  1. Ethics: The study will be conducted in accordance with the declaration of Helsinki, REGULATION (EU) 2017/745, EN ISO 14155:2020, FDA 21 CFR parts 50, 54, 56, 812 and other applicable local and national regulations.
Being tested
Renal denervation
Keywords
Uncontrolled Hypertension, Autosomal Dominant Polycystic Kidney Disease, Renal denervation
Medical subject headings
Polycystic Kidney, Autosomal Dominant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal denervationDevice

    The Paradise® Renal Denervation System (Paradise System) is CE-marked in countries accepting the CE mark. The system is a catheter-based device designed to use ultrasound energy to thermally ablate the afferent and efferent nerves surrounding the renal artery and serving the kidney.

Study groups in NCT05460169
Study groupRoleWhat they receive
Immediate Renal Denervation Group (I-RDN-group)Active comparatorPatients are randomized into (immediate) I-RDN-group and (delayed) D-RDN-group, respectively. All subjects in the I-RDN-group will undergo a diagnostic, renal angiogram immediately (based on clinical grounds to rule out renal artery stenosis), which should be per Institutional practice via femoral artery access. Renal Denervation procedure will be applied using the Paradise® Renal Denervation System. The Paradise® Renal Denervation System is a catheter-based device designed to use ultrasound energy to thermally ablate the afferent and efferent nerves surrounding the renal artery and serving the kidney.
Receives: Device: Renal denervation
Delayed Renal Denervation Group (D-RDN-group)Other3 months after randomization, patients in the (delayed) D-RDN-group will undergo renal denervation procedure after undergoing a diagnostic, renal angiogram and will be followed for additional 36 months.
Receives: Device: Renal denervation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in systolic 24-h ambulatory BP [whole study group]

    change in systolic 24-h ambulatory BP at 3 months post-procedure from pre-treatment in the whole study group (irrespective whether treated immediate [I-RDN-group] or delayed [D-RDN-group]).

    Measured: 3 months post-procedure

Secondary outcomes (32)

  1. Change in diastolic 24-h ambulatory BP [whole study group]

    Change in diastolic 24-h ambulatory BP at 3 months post-procedure in the whole study group (irrespetive whether treated immmediate (I-RDN-group) or delayed (D-RDN-group) compared to pre-treatment

    Measured: 3 months post-procedure

  2. Change in systolic and diastolic 24-h ambulatory BP [whole study group]

    Change in systolic and diastolic 24-h ambulatory BP at 6, 12, 18, 24, 30 and 36 months post-procedure in the whole study group (irrespective whether treated immediate [I-RDN-group] or delayed [D-RDN-group]) compared to pre-treatment

    Measured: 6, 12, 18, 24, 30, 36 months post-procedure

  3. Change in systolic and diastolic 24-h ambulatory BP [separate study groups]

    Change in systolic and diastolic 24-h ambulatory BP at 3 months post-procedure from pre-treatment in the I-RDN-group versus the change in systolic 24-h ambulatory BP prior procedure from pre-treatment in D-RDN-group

    Measured: 3 months post-procedure

  4. Responder rate in BP [separate study groups]

    Responder rate in BP (systolic office BP ≥ 5 mmHg, or 24-h systolic ambulatory BP ≥ 3 mmHg) at 3 months pre-treatment in the I-RDN-group versus responder rate in BP from pre-treatment to 3 months later in the D-RDN-group.

    Measured: 3 months post-procedure

  5. Change in systolic and diastolic office (attended) BP [whole study group]

    Change in systolic and diastolic office (attended) BP at 3, 6, 12, 18 and 24, 30, 36 months post-procedure in the whole study group compared to pre-treatment

    Measured: 3, 6, 12, 18, 24, 30, 36 months post-procedure

  6. Change in systolic and diastolic office (attended) BP [separate study groups]

    Change in systolic office (attended) BP at 3 months post-procedure from pre-treatment in the I-RDN-group versus the change prior procedure from pre-treatment in D-RDN-group

    Measured: 3 months post-procedure

  7. Change in systolic and diastolic home BP (IEM-Tel-O-Graph-GSM) [whole study group]

    Change in systolic and diastolic home BP (IEM-Tel-O-Graph-GSM) at 3, 6, 12, 24 and 36 months post-procedure in the whole study group compared to pre-treatment

    Measured: 3, 6, 12, 24 and 36 months post-procedure

  8. Change in systolic and diastolic home BP (IEM-Tel-O-Graph-GSM) [separate study groups]

    Change in systolic and diastolic home BP at 3 months post-procedure in the I-RDN-group versus the change prior procedure from pre-treatment in D-RDN-group.

    Measured: 3 months post-procedure

  9. Win ratio analysis (BP change and decrease of medication number) [separate study groups]

    Win ratio analysis will be conducted, with the criteria 24h ambulatory systolic BP change > 3 mmHg, office systolic BP change > 5 mmHg, and decrease of medication number from pre-treatment to 3 month post procedure in the I-RDN group versus pre-treatment to 3 months later in D-RDN-group.

    Measured: 3 months post-procedure

  10. Win ratio analysis (BP change and decrease of drug burden index ) [separate study groups]

    Win ratio analysis will be conducted, with the criteria 24h ambulatory systolic BP change > 3 mmHg, office systolic BP change > 5 mmHg, and any decrease of drug burden index from pre-treatment to 3 month post procedure in the I-RDN group versus pre-treatment to 3 months later in D-RDN-group.

    Measured: 3 months post-procedure

  11. Win ratio analysis (BP change and decrease of antihypertensive load index ) [separate study groups]

    Win ratio analysis will be conducted, with the criteria 24h ambulatory systolic BP change > 3 mmHg, office systolic BP change > 5 mmHg, and any decrease of antihypertensive load index from pre-treatment to 3 month post procedure in the I-RDN group versus pre-treatment to 3 months later in D-RDN-group

    Measured: 3 months post-procedure

  12. Change in serum creatinine derived estimated glomerular filtration rate (eGFR) [whole study group]

    Change in serum creatinine derived estimated glomerular filtration rate (eGFR) at 3, 6, 12, 18 and 24, 30 and 36 months post-procedure in the whole study group compared to pre-treatment

    Measured: 3, 6, 12, 18 and 24, 30, 36 months post-procedure

  13. Change in cystatin C derived eGFR [whole study group]

    Change in cystatin C derived estimated glomerular filtration rate (eGFR) at 3, 6, 12, 18 and 24, 30, 36 months post-procedure in the whole study group compared to pre-treatment

    Measured: 3, 6, 12, 18 and 24, 30, 36 months post-procedure

  14. Change in total kidney volume (assessed by magnetic resonance imaging) [whole study group]

    Change in total kidney volume (assessed by magnetic resonance imaging) at 6, 12, 24, 36 months post-procedure in the whole study group compared to pre-treatment

    Measured: 6, 12, 24, 36 months post-procedure

  15. Change in measured GFR (assessed by single-shot iohexol clearance) [whole study group]

    Change in measured GFR (assessed by single-shot iohexol clearance) at 6, 12, 24 and 36 months post-procedure in the whole study group compared to pre-treatment

    Measured: 6, 12, 24, 36 months post-procedure

  16. Change in proteinuria [whole study group]

    Change in proteinuria (per g urinary creatinine) at 3, 6, 12, 18, 24, 30 and 36 months post-procedure from pre-treatment.

    Measured: 3, 6, 12, 18, 24, 30 and 36 months post-procedure

  17. Change in albuminuria [whole study group]

    Change in albuminuria (per g urinary creatinine) at 3, 6, 12, 18, 24, 30 and 36 months post-procedure from pre-treatment.

    Measured: 3, 6, 12, 18, 24, 30 and 36 months post-procedure

  18. Change in urine sodium [whole study group]

    Change in urine sodium (per g urinary creatinine) at 3, 6, 12, 18, 24, 30 and 36 months post-procedure from pre-treatment.

    Measured: 3, 6, 12, 18, 24, 30 and 36 months post-procedure

  19. Change in urine potassium [whole study group]

    Change in urine potassium (per urinary creatinine) at 3, 6, 12, 18, 24, 30 and 36 months post-procedure from pre-treatment.

    Measured: 3, 6, 12, 18, 24, 30 and 36 months post-procedure

  20. Change in urine creatinine concentration [whole study group]

    Change in urine creatinine concentration at 3, 6, 12, 18, 24, 30 and 36 months post-procedure from pre-treatment.

    Measured: 3, 6, 12, 18, 24, 30 and 36 months post-procedure

  21. Change of the slope of eGFR [whole study group]

    Change of the slope of eGFR after 3, 6, 12, 18, 24, 30 and 36 months post-procedure from pre-treatment compared to the historical slope the year before in the total study group.

    Measured: 3, 6, 12, 18, 24, 30 and 36 months post-procedure

  22. Change in serum creatinine derived eGFR [separate study groups]

    Change in serum creatinine derived eGFR at 3 months post-procedure from pre-treatment in the I-RDN-group versus the change prior procedure from pre-treatment in D-RDN-group

    Measured: 3 months post-procedure

  23. Change in cystatin C derived eGFR [separate study groups]

    Change in cystatin C derived eGFR at 3, 6, 12, 18 and 24, 30, 36 months post-procedure from pre-treatment in the I-RDN-group versus the change prior procedure from pre-treatment in D-RDN-group

    Measured: 3 months post-procedure

  24. Change in proteinuria [separate study groups]

    Change in proteinuria from pre-procedure pre-treatment in the I-RDN-group versus the change from pre-treatment to 3 months later in the D-RDN-group.

    Measured: 3 months post-procedure

  25. Change in albuminuria [separate study groups]

    Change in albuminuria from pre-procedure pre-treatment in the I-RDN-group versus the change from pre-treatment to 3 months later in the D-RDN-group.

    Measured: 3 months post-procedure

  26. Change in urine sodium [separate study groups]

    Change in urine sodium from pre-procedure pre-treatment in the I-RDN-group versus the change from pre-treatment to 3 months later in the D-RDN-group.

    Measured: 3 months post-procedure

  27. Change in urine potassium [separate study groups]

    Change in urine potassium from pre-procedure pre-treatment in the I-RDN-group versus the change from pre-treatment to 3 months later in the D-RDN-group.

    Measured: 3 months post-procedure

  28. Change in urine creatinine concentration [separate study groups]

    Change in urine creatinine concentration from pre-procedure pre-treatment in the I-RDN-group versus the change from pre-treatment to 3 months later in the D-RDN-group.

    Measured: 3 months post-procedure

  29. Change of the slope of eGFR [separate study groups]

    Change of the slope of eGFR after 3 month post-procedure from pre-treatment (including eGFR values) in the I-RDN group compared to change after 3 month FU from pre-treatment in the D-RDN group.

    Measured: 3 month post-procedure

  30. Level of pain (related to autosomal dominant polycystic kidney disease) determined by the use of a visual analogue scale [whole study group]

    Level of pain (related to autosomal dominant polycystic kidney disease) determined by the use of a visual analogue scale (minimum value=0, representing no pain; maximum value=100, representing most imaginable pain) at 3, 6, 12, 24, 36 months post-procedure in the whole study group compared to pre-treatment.

    Measured: 3, 6, 12, 24, 36 months post-procedure

  31. Change in Quality of life (QoL) (e.g. EQ-5D-5L) [whole study group]

    Change in Quality of life (QoL) (e.g. EQ-5D-5L; minimum value=0, representing best imaginable health status; maximum value=100, representing worst imaginable health status) at 3, 6, 12, 24 and 36 months post-procedure in the whole study group compared to pre-treatment

    Measured: 3, 6, 12, 24 and 36 months post-procedure

  32. Change in plasma and urinary biomarkers (e.g. albumin, copeptin)

    Change in plasma and urinary biomarkers (e.g. albumin, copeptin) at 6, 12 months post-procedure in the whole study group compared to pre-treatment

    Measured: 6, 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2022
  2. Study start14 Jun 2022
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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
RDN-ADPKD is a prospective, randomized (1:1, central randomization), single-centre, hypothesis-generating, feasibility study. Patients are randomized into I-RDN-group and D-RDN-group, respectively. After 3 months, patients in the D-RDN-group will undergo RDN-procedure and will be followed for additional 36 months. Hence, study design allows several comparisons both of whole study group (at same time-point of follow-up) as well as between I-RDN-group and D-RDN-group.
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05460169
Sponsor's protocol ID
RDN2021ADPKD
Acronym
RDN-ADPKD
Status last verified
Apr 2026
First submitted
15 Jun 2022
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

    PubMed 39356039

Questions about this trial

What is this clinical trial studying?

A study testing Renal denervation in people with Uncontrolled Hypertension and Autosomal Dominant Polycystic Kidney Disease, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

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 4 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 5 May 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 Germany. 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in systolic 24-h ambulatory BP [whole study group] (time frame: 3 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05460169, which also lists 1 linked publication.

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 5 May 2026.

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