Uncontrolled HypertensionRDN-CKD GRNCT07742787
Renal Denervation in Chronic Kidney Disease - RDN-CKD Study
A study testing Renal denervation in people with Uncontrolled Hypertension and Renal Denervation, run by Hippocration General Hospital at 1 site in Greece.
Trial summary
RDN-CKD GR Study is a prospective, randomized (1:1), double-blind (unblinded interventionalist and blinded study team), sham controlled study. The purpose of the RDN-CKD GR Study is to demonstrate that renal denervation (RDN) effectively reduces 24-h ambulatory BP in 20 patients with chronic kidney disease (CKD) stage… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Hypertension, Renal Denervation, Chronic Kidney Disease (Stage 3)
- What is being tested?
- Renal denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 4 Jul 2024to 7 Mar 2027
- Phase
- Interventional
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
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Renal Denervation on Blood Pressure in Patients With Chronic Kidney Disease and Uncontrolled Hypertension
RDN-CKD GR Study is a prospective, randomized (1:1), double-blind (unblinded interventionalist and blinded study team), sham controlled study. The purpose of the RDN-CKD GR Study is to demonstrate that renal denervation (RDN) effectively reduces 24-h ambulatory BP in 20 patients with chronic kidney disease (CKD) stage 3a or 3b.
Read the detailed description
Introduction Uncontrolled hypertension is more prevalent in patients with chronic kidney disease (CKD) and the risk of developing end-stage renal disease is increased in patients with uncontrolled hypertension. Clinical and experimental studies have clearly shown that sympathetic nerve activity is increased in CKD and substantially aggravates the progression of CKD. Recent clinical studies have indicated that invasive, catheter-based renal denervation (RDN) decreases the sympathetic nerve activity in the whole body and in particular in the kidneys. In patients with primary hypertension washed off of antihypertensive medications, RDN has been found to significantly decrease blood pressure (BP) in two randomized, double blind, sham-controlled studies.
Study Purpose The purpose of the RDN-CKD Study is to demonstrate that RDN effectively reduces 24-h ambulatory BP in patients with CKD stage 3.
Study Design RDN-CKD Study is a prospective, randomized (1:1, central randomization), double-blind (unblinded interventionalist and blinded study team at each center), sham controlled feasibility study.
Patient Population 20 patients with CKD stages 3a or 3b (according to the currently used estimation formulas [MDRD, CKD-EPI] and uncontrolled hypertension.
Endpoints - Primary Efficacy Endpoint The primary efficacy endpoint will be the change in systolic 24-h ambulatory BP at 6 months post-procedure compared between the 2 groups.
Visit and Follow-Up Schedule The primary efficacy endpoint will be assessed at 26 weeks (6 months) post-procedure in both cohorts; however, all subjects will be followed for a minimum of 12 months post-procedure. Scheduled in-clinic follow-up (FU) visits will occur at 3, 6, 12 (3 months), 19, 26 (6 months), 39 and 52 (12 months) weeks post procedure.
Blinding The subjects and all study personnel taking BP measurements will be blinded to the randomization. Subjects will complete a blinding assessment prior to hospital pre-discharge and at 3 weeks and 6 months FU.
Crossover to treatment Crossover of patients allocated to the sham group is allowed after 12 months. At that time, after 12 months of blinded FU, unblinding of the individual patient takes place. To be eligible for crossover treatment, patients have to fulfill the same BP criteria as specified at the inclusion criteria and exclusion criteria within the next 4 weeks after FU.
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, 6 months, and 12 months visit.
Safety Signals A major combined safety endpoint is the incidence of any major adverse events (MAE) through the 12 months FU.
Study Geographies The RDN-CKD Study will be conducted at First Cardiology Department, School of Medicine, National and Kapodistrian University of Athens, Hippocratio General Hospital
Escape Criteria Enrolled subjects will be excluded if office (attended) BP exceeds ≥170/105 mmHg confirmed by 7-day average of home blood pressure measurements ≥ BP >160/100 mmHg or confirmed by office (attended) BP ≥170/105 mmHg at another study visit.
13 Ethics The study will be conducted in accordance with the declaration of Helsinki, ISO 14155:2011, FDA 21 CFR parts 50, 54, 56, 812 and other applicable local and national regulations.
- Being tested
- Renal denervation, Sham procedure control
- Keywords
- uncontrolled hypertension, renal denervation, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
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.
Sham procedure controlDiagnostic test
sham procedure
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Active comparator | All subjects will undergo a diagnostic computed tomography angiography (CTA) or magnetic resonance angiography (MRA) of renal arteries, and a pre-procedural renal angiogram (based on clinical grounds to rule out renal artery stenosis and confirm eligibility criteria) which should be per Institutional practice via femoral artery access. Randomization will occur following the diagnostic renal angiogram. If randomized to the Renal Denervation Group RDN 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 |
| Sham | Sham comparator | All subjects will undergo a diagnostic computed tomography angiography (CTA) or magnetic resonance angiography (MRA) of the renal arteries, followed by a pre-procedural renal angiogram (based on clinical grounds to rule out renal artery stenosis and confirm eligibility criteria) which should be per Institutional practice via femoral artery access. Randomization will occur following the diagnostic renal angiogram. In these patients no RDN will be performed. Receives: Diagnostic Test: Sham procedure control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in systolic 24-h ambulatory BP
compared between the 2 groups
Measured: at 6 month post-procedure
Secondary outcomes (8)
Change in systolic 24-h ambulatory BP
compared between the 2 groups
Measured: at 3 and 12 month post-procedure
Change in diastolic 24-h ambulatory BP at 3, 6 and 12 months post-procedure
compared between the 2 groups
Measured: at 3, 6 and 12 months post-procedure
Change in office (attended) systolic and diastolic BP
between the 2 groups
Measured: at 3, 6 and 12 months post-procedure
Responder rate in BP (systolic office (attended) BP ≥10 mmHg, 24-h systolic ambulatory BP ≥ 5 mmHg)
compared between the 2 groups
Measured: at 3, 6 and 12 months post-procedure
Change in estimated glomerular filtration rate [eGFR]
compared between the 2 groups
Measured: at 3, 6 and 12 months post-procedure
Change of the slope of eGFR
compared between the 2 groups
Measured: after half year and one year post-procedure
Change of the slope of eGFR
compared to the historical slope the year before
Measured: at 1 year post-procedure
Change in albuminuria quantitatively and by category
compared between the 2 groups
Measured: at 6 and 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.
- First posted3 Aug 2026
- Study start4 Jul 2024
- Primary completion6 Sep 2026 (estimated)
- Study completion7 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ReCor Medical, Inc.
- Responsible party
- Principal investigator, Konstantinos Tsioufis, Hippocration General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742787
- Sponsor's protocol ID
- RDN2022CKDGR
- Acronym
- RDN-CKD GR
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abid S, Mehta S, Munazzah F, Yager N, Baloch S, Hongalgi K. Renal Denervation: A New Era in the Management of Resistant Hypertension. Kidney360. 2025 Nov 1;6(11):2010-2016. doi: 10.34067/KID.0000000961. Epub 2025 Aug 13.
PubMed 40802676Ott C, Schmid A, Ditting T, Veelken R, Uder M, Schmieder RE. Effects of renal denervation on blood pressure in hypertensive patients with end-stage renal disease: a single centre experience. Clin Exp Nephrol. 2019 Jun;23(6):749-755. doi: 10.1007/s10157-019-01697-7. Epub 2019 Feb 19.
PubMed 30783914Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, Saxena M, Feyz L, Rader F, Lurz P, Sayer J, Sapoval M, Levy T, Sanghvi K, Abraham J, Sharp ASP, Fisher NDL, Bloch MJ, Reeve-Stoffer H, Coleman L, Mullin C, Mauri L; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23.
PubMed 29803590Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.
PubMed 29803589Krum H, Schlaich MP, Sobotka PA, Bohm M, Mahfoud F, Rocha-Singh K, Katholi R, Esler MD. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014 Feb 15;383(9917):622-9. doi: 10.1016/S0140-6736(13)62192-3. Epub 2013 Nov 7.
PubMed 24210779Mahfoud F, Schmieder RE, Azizi M, Pathak A, Sievert H, Tsioufis C, Zeller T, Bertog S, Blankestijn PJ, Bohm M, Burnier M, Chatellier G, Durand Zaleski I, Ewen S, Grassi G, Joner M, Kjeldsen SE, Lobo MD, Lotan C, Luscher TF, Parati G, Rossignol P, Ruilope L, Sharif F, van Leeuwen E, Volpe M, Windecker S, Witkowski A, Wijns W. Proceedings from the 2nd European Clinical Consensus Conference for device-based therapies for hypertension: state of the art and considerations for the future. Eur Heart J. 2017 Nov 21;38(44):3272-3281. doi: 10.1093/eurheartj/ehx215. No abstract available.
PubMed 28475773Mahfoud F, Cremers B, Janker J, Link B, Vonend O, Ukena C, Linz D, Schmieder R, Rump LC, Kindermann I, Sobotka PA, Krum H, Scheller B, Schlaich M, Laufs U, Bohm M. Renal hemodynamics and renal function after catheter-based renal sympathetic denervation in patients with resistant hypertension. Hypertension. 2012 Aug;60(2):419-24. doi: 10.1161/HYPERTENSIONAHA.112.193870. Epub 2012 Jun 25.
PubMed 22733462Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, Ewen S, Tsioufis K, Tousoulis D, Sharp ASP, Watkinson AF, Schmieder RE, Schmid A, Choi JW, East C, Walton A, Hopper I, Cohen DL, Wilensky R, Lee DP, Ma A, Devireddy CM, Lea JP, Lurz PC, Fengler K, Davies J, Chapman N, Cohen SA, DeBruin V, Fahy M, Jones DE, Rothman M, Bohm M; SPYRAL HTN-OFF MED trial investigators*. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-2170. doi: 10.1016/S0140-6736(17)32281-X. Epub 2017 Aug 28.
PubMed 28859944Azizi M, Sapoval M, Gosse P, Monge M, Bobrie G, Delsart P, Midulla M, Mounier-Vehier C, Courand PY, Lantelme P, Denolle T, Dourmap-Collas C, Trillaud H, Pereira H, Plouin PF, Chatellier G; Renal Denervation for Hypertension (DENERHTN) investigators. Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet. 2015 May 16;385(9981):1957-65. doi: 10.1016/S0140-6736(14)61942-5. Epub 2015 Jan 26.
PubMed 25631070Oparil S, Schmieder RE. New approaches in the treatment of hypertension. Circ Res. 2015 Mar 13;116(6):1074-95. doi: 10.1161/CIRCRESAHA.116.303603.
PubMed 25767291Ott C, Mahfoud F, Schmid A, Toennes SW, Ewen S, Ditting T, Veelken R, Ukena C, Uder M, Bohm M, Schmieder RE. Renal denervation preserves renal function in patients with chronic kidney disease and resistant hypertension. J Hypertens. 2015 Jun;33(6):1261-6. doi: 10.1097/HJH.0000000000000556.
PubMed 25923731Schlaich MP, Bart B, Hering D, Walton A, Marusic P, Mahfoud F, Bohm M, Lambert EA, Krum H, Sobotka PA, Schmieder RE, Ika-Sari C, Eikelis N, Straznicky N, Lambert GW, Esler MD. Feasibility of catheter-based renal nerve ablation and effects on sympathetic nerve activity and blood pressure in patients with end-stage renal disease. Int J Cardiol. 2013 Oct 3;168(3):2214-20. doi: 10.1016/j.ijcard.2013.01.218. Epub 2013 Feb 28.
PubMed 23453868Vonend O, Marsalek P, Russ H, Wulkow R, Oberhauser V, Rump LC. Moxonidine treatment of hypertensive patients with advanced renal failure. J Hypertens. 2003 Sep;21(9):1709-17. doi: 10.1097/00004872-200309000-00021.
PubMed 12923404Converse RL Jr, Jacobsen TN, Toto RD, Jost CM, Cosentino F, Fouad-Tarazi F, Victor RG. Sympathetic overactivity in patients with chronic renal failure. N Engl J Med. 1992 Dec 31;327(27):1912-8. doi: 10.1056/NEJM199212313272704.
PubMed 1454086Veelken R, Schmieder RE. Renal denervation--implications for chronic kidney disease. Nat Rev Nephrol. 2014 Jun;10(6):305-13. doi: 10.1038/nrneph.2014.59. Epub 2014 Apr 15.
PubMed 24733118