Renal Denervation in Chronic Kidney Disease - RDN-CKD Study

NCT04264403 | Completed DMC

• 1 other identifier: RDN2019CKD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

Brief Summary

RDN-CKD Study is a prospective, randomized (1:1, central randomization), double-blind (unblinded interventionalist and blinded study team at each center), sham controlled, multicenter feasibility study. The purpose of the RDN-CKD Study is to demonstrate that renal denervation (RDN) effectively reduces 24-h ambulatory BP in 80 patients with chronic kidney disease (CKD) stage 3a or 3b.

Conditions

Uncontrolled Hypertension; Renal Denervation; Chronic Kidney Disease stage3

Keywords

Chronic Kidney Disease; Renal Denervation; Uncontrolled Hypertension

Outcome Measures

Primary Outcomes (1)

• change in systolic 24-h ambulatory BP

  compared between the 2 groups (updated; please see details in the SAP uploaded)

  at 6 month post-procedure

Secondary Outcomes (8)

• Change in systolic 24-h ambulatory BP

  at 3 and 12 month post-procedure

• Change in diastolic 24-h ambulatory BP at 3, 6 and 12 months post-procedure

  at 3, 6 and 12 months post-procedure

• Change in office (attended) systolic and diastolic BP

  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)

  at 3, 6 and 12 months post-procedure

• Change in estimated glomerular filtration rate [eGFR]

  at 3, 6 and 12 months post-procedure

Study Arms (2)

Renal Denervation

ACTIVE COMPARATOR

All subjects will undergo a diagnostic, renal angiogram (based on clinical grounds to rule out renal artery stenosis) 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.

Device: Renal denervation

Sham Procedere

NO INTERVENTION

All subjects will undergo a diagnostic, renal angiogram (based on clinical grounds to rule out renal artery stenosis) 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.

Interventions

Renal denervation DEVICE

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.

Renal Denervation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (4)

Heinrich Heine University Düsseldorf, Nephrologie, Germany

Düsseldorf, 40225, Germany

Location

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

Erlangen, 91054, Germany

Location

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

Homburg, 66421, Germany

Location

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

Nuremberg, Germany

Location

Related Publications (18)

• Klag MJ, Whelton PK, Randall BL, Neaton JD, Brancati FL, Ford CE, Shulman NB, Stamler J. Blood pressure and end-stage renal disease in men. N Engl J Med. 1996 Jan 4;334(1):13-8. doi: 10.1056/NEJM199601043340103.

  PMID: 7494564 BACKGROUND

• Chowdhury EK, Langham RG, Ademi Z, Owen A, Krum H, Wing LM, Nelson MR, Reid CM; Second Australian National Blood Pressure Study Management Committee. Rate of change in renal function and mortality in elderly treated hypertensive patients. Clin J Am Soc Nephrol. 2015 Jul 7;10(7):1154-61. doi: 10.2215/CJN.07370714. Epub 2015 Apr 21.

  PMID: 25901093 BACKGROUND

• Hering D, Mahfoud F, Walton AS, Krum H, Lambert GW, Lambert EA, Sobotka PA, Bohm M, Cremers B, Esler MD, Schlaich MP. Renal denervation in moderate to severe CKD. J Am Soc Nephrol. 2012 Jul;23(7):1250-7. doi: 10.1681/ASN.2011111062. Epub 2012 May 17.

  PMID: 22595301 BACKGROUND

• Veelken 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.

  PMID: 24733118 BACKGROUND

• Converse 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.

  PMID: 1454086 BACKGROUND

• Vonend 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.

  PMID: 12923404 BACKGROUND

• Schlaich 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.

  PMID: 23453868 BACKGROUND

• Ott 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.

  PMID: 25923731 BACKGROUND

• Oparil 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.

  PMID: 25767291 BACKGROUND

• Azizi 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.

  PMID: 25631070 BACKGROUND

• Townsend 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.

  PMID: 28859944 BACKGROUND

• Mahfoud 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.

  PMID: 22733462 BACKGROUND

• Mahfoud 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. Erratum In: Eur Heart J. 2018 May 1;39(17):1534. doi: 10.1093/eurheartj/ehx290.

  PMID: 28475773 BACKGROUND

• Krum 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.

  PMID: 24210779 BACKGROUND

• Kandzari 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.

  PMID: 29803589 BACKGROUND

• Azizi 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.

  PMID: 29803590 BACKGROUND

• Ott 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.

  PMID: 30783914 BACKGROUND

• 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.

  PMID: 40802676 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roland E Schmieder, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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, 6 months and 12 months FU.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RDN-CKD Study is a prospective, randomized (1:1, central randomization), double-blind (unblinded interventionalist and blinded study team at each center), sham controlled, multicenter feasibility study.

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 11, 2020
• Study Start: January 23, 2020
• Primary Completion: November 23, 2023
• Study Completion: April 16, 2024
• Last Updated: April 30, 2026

Record last verified: 2025-06

Locations

DE (4)