Renal Denervation in Chronic Kidney Disease - RDN-CKD Study

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Uncontrolled Hypertension, Renal Denervation, Chronic Kidney Disease (Stage 3)

In brief

RDN-CKD GR Study is a prospective, randomized (1:1), double-blind (unblinded interventionalist and blinded study team), sham controlled study. The purpose of the RDN-CKD GR Study is to demonstrate that renal denervation (RDN) effectively reduces 24-h ambulatory BP in 20 patients with chronic kidney disease (CKD) stage 3a or 3b.

Key facts

Study ID

NCT07742787

Run by

Hippocration General Hospital

People needed

20

Starts

2024-07-04

Expected to finish

2027-03-07

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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)

Where it is running

• Hippocratio General Hospital — Athens, Greece

Full record on ClinicalTrials.gov

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