Assessment of Early GFR, Tubular Function and Pathology Changes Early and Late After Renal denervatioN

NCT07786636 | Not Yet Recruiting

• 1 other identifier: RO-250206
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical study is to better understand how renal denervation (RDN) affects kidney function, both shortly after and up to a year after the procedure. Renal denervation is a minimally invasive treatment used for patients with high blood pressure that does not respond well to medication ("resistant hypertension"). It works by reducing the activity of nerves that run along the arteries supplying the kidneys, which helps lower blood pressure. To understand how RDN affects the kidneys, we will measure kidney function in detail and analyse blood and urine samples collected before and after the procedure. This will help researchers see whether the procedure causes changes in the kidneys, and whether some of these changes are linked to better kidney health over time.

Conditions

Renal Denervation Therapy

Outcome Measures

Primary Outcomes (1)

• Change of a specific protein score in urine between Baseline visit (Day 1) and 12 months follow-up visit

  Change of a specific protein score in urine prior to standard of care index procedure and 12 months from index procedure. Samples will be stored until the last patient had the last visit. All measurements will be then done afterwards.

  Baseline visit (Day 1) and 12 months follow-up visit

Study Arms (1)

Patients who will undergo a renal denervation procedure within their standard of care

OTHER

bio sample collection (blood, urine)

Diagnostic Test: blood sampling

Interventions

blood sampling DIAGNOSTIC_TEST

Blood samples will be taken to examine the mGFR as parameter for kidney function

Patients who will undergo a renal denervation procedure within their standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years
• eGFR \>30 ml/min/1.73m2 (CKD stages 3b and less severe)
• Informed consent for study participation provided by the patient or the legal guardian
• Patient information and consent to the processing of personal data
• Stable therapy in the previous three months
• All patients undergoing RDN for clinical indications

You may not qualify if:

• Patients in emergency situations
• Turbid urine sample on admission
• Visible haematuria in the urine sample on admission
• Pregnancy
• Allergy to contrast media (visipaque, omnipaque, iohexol)
• Any problem, which, in the investigator's opinion, might jeopardize the participant's compliance with the protocol.

Sponsors & Collaborators

• Rede Optimus Hospitalar SA: lead

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Alexandra Greindl, Dr

CONTACT

+49 157 851 281 40; alexandra.greindl@redeoptimus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share