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NCT04264403Completed

Renal Denervation in Chronic Kidney Disease - RDN-CKD Study

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

Source: ClinicalTrials.gov · Last updated 30 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
44 (actual)
First submitted
31 Jan 2020
Start date
23 Jan 2020
Primary completion date
23 Nov 2023
Lead sponsor
University of Erlangen-Nürnberg Medical School
NCT number
NCT04264403

What you commit to

  • Study type: Interventional
  • Participants enrolled: 44
  • From 23 Jan 2020 to the primary completion date, 23 Nov 2023
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior renal denervation procedure
  • Anatomic or functional solitary kidney, kidney transplantation

Other illness

  • Other cause of Hypertension that can be treated by Intervention/surgery (e.g. hemodynamically relevant renal artery stenosis, functional adrenal adenoma)
  • Secondary hypertension other than obstructive sleep apnea
  • Type 1 diabetes mellitus
  • Nephrotic syndrome
  • 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
  • Any condition that, at the discretion of the investigator, would preclude participation in the study (e.g. non-adherence)

Lab values

  • Lack of capturing serum creatinine levels in the past

Other

  • Anatomically significant renal artery abnormality in either renal artery which in the eyes of the interventionalist would interfere with safe catheter Placement
  • Office (attended) BP ≥ 180 mmHg systolic and/or ≥ 110 mmHg diastolic
  • 24-h ambulatory BP ≥ 160 mmHg systolic
  • Contraindication to magnetic resonance imaging (MRI)
  • Subject is pregnant, nursing, or intends to become pregnant
  • Enrollment in another interventional research protocol.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Heinrich Heine University Düsseldorf, Nephrologie, Germany
Coordinator of this site? Confirm its status
DüsseldorfGermanyUnknown status
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg
Coordinator of this site? Confirm its status
ErlangenGermanyUnknown status
Klinik für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Saarland University Hospital, Saarland University
Coordinator of this site? Confirm its status
HomburgGermanyUnknown status
Clinical Research Center Nuremberg, Department of Nephrology, University Hospital Erlangen
Coordinator of this site? Confirm its status
NurembergGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.