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
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heinrich Heine University Düsseldorf, Nephrologie, Germany Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Klinik für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Saarland University Hospital, Saarland University Coordinator of this site? Confirm its status | Homburg | Germany | Unknown status |
| Clinical Research Center Nuremberg, Department of Nephrology, University Hospital Erlangen Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.