Renal Denervation in Chronic Kidney Disease - RDN-CKD Study (RDN-CKD)

December 14, 2023 updated by: University of Erlangen-Nürnberg Medical School

Effect of Renal Denervation on Blood Pressure in Patients With Chronic Kidney Disease and Uncontrolled Hypertension

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 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.
  2. 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.
  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, multicenter feasibility study. All centers have participated at least in one of the sham-controlled trials in primary hypertension thereby having established an unblinded and a blinded team.
  4. Patient Population

80 patients with CKD stages 3a or 3b (according to the currently used estimation formulas [MDRD, CKD-EPI] and uncontrolled hypertension.

5 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.

6 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.

7 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.

8 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.

All randomized patients will be included in a registry after 12 months to capture long-term safety signals.

9 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.

10 Safety Signals A major combined safety endpoint is the incidence of any major adverse events (MAE) through the 12 months FU.

11 Study Geographies The RDN-CKD Study will be conducted at 4 clinical investigational sites, which are the University Hospitals in Erlangen, Homburg/Saar, Düsseldorf, and Nürnberg.

12 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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Duesseldorf, Germany, 40225
        • Heinrich Heine University Düsseldorf, Nephrologie, Germany
      • Erlangen, Germany, 91054
        • Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg
      • Homburg, Germany, 66421
        • Klinik für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Saarland University Hospital, Saarland University
      • Nuremberg, Germany
        • Clinical Research Center Nuremberg, Department of Nephrology, University Hospital Erlangen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 6 month post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 3 and 12 month post-procedure
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)
at 3, 6 and 12 months post-procedure
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)
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)
Time Frame: at 3, 6 and 12 months post-procedure
compared between the 2 groups (updated; please see details in the SAP uploaded)
at 3, 6 and 12 months post-procedure
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)
at 3, 6 and 12 months post-procedure
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)
after half year and one year post-procedure
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)
at 1 year post-procedure
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)
at 6 and 12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Roland E Schmieder, MD, Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2020

Primary Completion (Estimated)

December 23, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

February 8, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDN2019CKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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