Renal Denervation in Chronic Kidney Disease - RDN-CKD Study (RDN-CKD)
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ClinicalTrials.gov Identifier: NCT04264403 |
Recruitment Status :
Active, not recruiting
First Posted : February 11, 2020
Last Update Posted : December 21, 2023
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Condition or disease | Intervention/treatment | Phase |
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Uncontrolled Hypertension Renal Denervation Chronic Kidney Disease stage3 | Device: Renal denervation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | 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. |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | Effect of Renal Denervation on Blood Pressure in Patients With Chronic Kidney Disease and Uncontrolled Hypertension |
Actual Study Start Date : | January 23, 2020 |
Estimated Primary Completion Date : | December 23, 2023 |
Estimated Study Completion Date : | December 30, 2023 |
Arm | Intervention/treatment |
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Active Comparator: Renal Denervation
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.
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Device: Renal denervation
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. |
No Intervention: Sham Procedere
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.
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- change in systolic 24-h ambulatory BP [ Time Frame: at 6 month post-procedure ]compared between the 2 groups (updated; please see details in the SAP uploaded)
- Change in systolic 24-h ambulatory BP [ Time Frame: at 3 and 12 month post-procedure ]compared between the 2 groups (updated; please see details in the SAP uploaded)
- Change in diastolic 24-h ambulatory BP at 3, 6 and 12 months post-procedure [ Time Frame: at 3, 6 and 12 months post-procedure ]compared between the 2 groups (updated; please see details in the SAP uploaded)
- Change in office (attended) systolic and diastolic BP [ Time Frame: at 3, 6 and 12 months post-procedure ]between the 2 groups (updated; please see details in the SAP uploaded)
- Responder rate in BP (systolic office (attended) BP ≥10 mmHg, 24-h systolic ambulatory BP ≥ 5 mmHg) [ Time Frame: at 3, 6 and 12 months post-procedure ]compared between the 2 groups (updated; please see details in the SAP uploaded)
- Change in estimated glomerular filtration rate [eGFR] [ Time Frame: at 3, 6 and 12 months post-procedure ]compared between the 2 groups (updated; please see details in the SAP uploaded)
- Change of the slope of eGFR [ Time Frame: after half year and one year post-procedure ]compared between the 2 groups (updated; please see details in the SAP uploaded)
- Change of the slope of eGFR [ Time Frame: at 1 year post-procedure ]compared to the historical slope the year before (updated; please see details in the SAP uploaded)
- Change in albuminuria quantitatively and by category [ Time Frame: at 6 and 12 months post-procedure ]compared between the 2 groups (updated; please see details in the SAP uploaded)
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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264403
Germany | |
Heinrich Heine University Düsseldorf, Nephrologie, Germany | |
Duesseldorf, Germany, 40225 | |
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg | |
Erlangen, Germany, 91054 | |
Klinik für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Saarland University Hospital, Saarland University | |
Homburg, Germany, 66421 | |
Clinical Research Center Nuremberg, Department of Nephrology, University Hospital Erlangen | |
Nuremberg, Germany |
Principal Investigator: | Roland E Schmieder, MD | Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg |
Documents provided by University of Erlangen-Nürnberg Medical School:
Responsible Party: | University of Erlangen-Nürnberg Medical School |
ClinicalTrials.gov Identifier: | NCT04264403 |
Other Study ID Numbers: |
RDN2019CKD |
First Posted: | February 11, 2020 Key Record Dates |
Last Update Posted: | December 21, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic Kidney Disease Renal Denervation Uncontrolled Hypertension |
Kidney Diseases Renal Insufficiency, Chronic Hypertension Vascular Diseases Cardiovascular Diseases Urologic Diseases Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Renal Insufficiency Chronic Disease Disease Attributes Pathologic Processes |