Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT04264403
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04264403
Study Brief:
Protocol Section:
NCT04264403