ClinicalTrials.gg
Not yet recruitingNCT07786636AEGEANUpdated Aug 26, 2026

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

An interventional study of blood sampling in Renal Denervation Therapy, sponsored by Rede Optimus Hospitalar SA. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Rede Optimus Hospitalar SA · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Denervation Therapy
03

In context

Lead sponsor

Rede Optimus Hospitalar SA is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥18 years
  • >30 ml/min/1.73m2 (CKD stages 3b and less severe)
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

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

    bio sample collection (blood, urine)

    Diagnostic Test: blood sampling

Interventions

  • Diagnostic testblood sampling

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

06

What researchers measure

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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Aug 2028, 23 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 26, 2026
StartEst.
Sep 2026
Primary completionEst.
Aug 2028
CompletionEst.
Aug 2028
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07786636
Lead sponsor
Rede Optimus Hospitalar SA
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Sep 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Aug 26, 2026

Study contacts

Alexandra Greindl, Dr
Contact
alexandra.greindl@redeoptimus.com
+49 157 851 281 40

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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