Chronic Kidney Disease PatientsGlikoOxENDNCT07437729
Glycocalyx and Oxidative Stress in Endothelial Function (Part 1)
An observational study of Chronic Kidney Disease Patients, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
The primary research objective of the project is to determine the role of eGC in microvascular reactivity in CKD (cross-sectional study 1). The main objective of the project is to increase the excellence and interdisciplinarity of scientific work at MEFOS by connecting researchers from different scientific fields… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease Patients
- How many people
- 105 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Oct 2025to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with CKD of hypertensive etiology, patients with hypertension and healthy volunteer subjects as controls.
Who may be able to join
- patients with CKD of hypertensive etiology (grades 1-2 and 3-5; eGFR CKD-EPI GFR ≥ 90 ml/min/1.73 m², i.e. < 60 mL/min/1.73 m2), non-diabetics, non-smokers
- patients with hypertension (according to ESH2023 Guidelines) without kidney damage (eGFR CKD-EPI >90 mL/min/1.73 m2) non-diabetics, non-smokers
- healthy volunteer subjects as controls
Who cannot join
- kidney disease of any other etiology except hypertension
- endocrine, autoimmune or inflammatory diseases that could affect kidney function.
- smoking
- diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
Osijek University Hospital
Osijek, 31000
About this study
Official title: The Role of Glycocalyx and Oxidative Stress in Endothelial Function (Part 1)
The primary research objective of the project is to determine the role of eGC in microvascular reactivity in CKD (cross-sectional study 1).
The main objective of the project is to increase the excellence and interdisciplinarity of scientific work at MEFOS by connecting researchers from different scientific fields, improving conditions and resources for scientific work, and increasing international cooperation, in line with strategic objective 1: raising scientific excellence. The results of the project could provide pathophysiological insight into the development and maintenance of endothelial dysfunction in CKD, as well as identify new biomarkers for CKD.
Read the detailed description
The primary objective of this project is to determine the role of endothelial glycocalyx (eGC) in impaired microvascular endothelium-dependent reactivity in patients with chronic kidney disease compared to healthy and hypertensive patients without complications (cross-sectional study 1).
Specific objective 1.1: Measure the reactivity of the peripheral microcirculation (using a laser Doppler blood flow meter) and the thickness of eGC (using Glycocheck) in the specified groups.
Specific objective 1.2: Quantify soluble markers of eGC, oxidative stress, and inflammation from serum samples and peripheral blood mononuclear cells (PBMC), as well as antioxidant capacity in the specified groups.
Specific objective 1.3: Determine the relationship between the results of functional tests, eGC, and markers from specific objective 1.2.
- Conditions
- Chronic Kidney Disease Patients
- Keywords
- Glycocalyx, Microcirculation, Endothelium, Inflammation, Oxidative Stress, Renal Insufficiency, Chronic
- Medical subject headings
- Inflammation, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease (CKD) group | Patients with CKD of hypertensive etiology, stages 1-2 and 3-5 (eGFR CKD-EPI GFR ≥ 90 ml/min/1.73 m², i.e. < 60 mL/min/1.73 m2), non-diabetics, non-smokers | |
| Hypertension (HT) group | Patients who have hypertension (according to ESH2023 Guidelines doi: 10.1097/HJH.0000000000003480) without kidney damage (eGFR CKD-EPI >90 mL/min/1.73 m2) non-diabetics, non-smokers | |
| Normotensive (NT) group | Healthy volunteer subjects as controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular reactivity
Skin microvascular reactivity in patients with chronic kidney disease compared to hypertensive patients and healthy subjects - assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, acetylcholine and sodium nitroprusside)
Measured: Baseline, at one time point (first visit to the laboratory)
Endothelial glycocalyx
Measurement of the thickness of eGC in the specified groups - measured by Glycocheck
Measured: Baseline, at one time point (first visit to the laboratory)
Secondary outcomes (4)
Endothelial glycocalyx soluble markers
Quantification of soluble markers of eGC from serum or plasma samples in the specified groups - measured by ELISA assays (syndecan-1, syndecan-4, glypican-1, MMP-9)
Measured: Baseline, at one time point (first visit to the laboratory)
Concentration of MPO, 8-iso prostaglandin F2a, OxLDL, AOPP and intracellular oxidative stress production
Quantification of oxidative stress biomarkers from serum samples and peripheral blood mononuclear cells (PBMC) in the specified groups - measured by ELISA assays (MPO, 8-iso prostaglandin F2a, OxLDL, AOPP) and flow cytometry (intracellulare oxidative stress production; DCF-DA and DHE)
Measured: Baseline, at one time point (first visit to the laboratory)
Macrophage frequency
Quantification of inflammation from peripheral blood mononuclear cells (PBMC) in the specified groups - flow cytometry (macrophage frequency)
Measured: Baseline, at one time point (first visit to the laboratory)
Antioxidant enzyme (SOD, CAT, GPx) concentration and activity
Quantification of antioxidative enzyme concentration and activation from serum samples in the specified groups - measured by ELISA assays and UV-Vis spectrophotometry (SOD, GPx, CAT)
Measured: Baseline, at one time point (first visit to the laboratory)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Oct 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
- Investigators
- Ines Drenjančević, MD, PhD, Study chair, Faculty of Medicine Josip Juraj Strossmayer University of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437729
- Sponsor's protocol ID
- 602-04/25-08/07
- Acronym
- GlikoOxEND
- Status last verified
- Oct 2025
- First submitted
- 16 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Glycocalyx and Oxidative Stress in Endothelial Function (Part 1)
- ClinicalTrials.gov ID
- NCT07437729
- Acronym / sponsor ID
- GlikoOxEND / 602-04/25-08/07
- Conditions
- Chronic Kidney Disease Patients
- Keywords
- Glycocalyx, Microcirculation, Endothelium, Inflammation, Oxidative Stress, Renal Insufficiency, Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary research objective of the project is to determine the role of eGC in microvascular reactivity in CKD (cross-sectional study 1).
The main objective of the project is to increase the excellence and interdisciplinarity of scientific work at MEFOS by connecting researchers from different scientific fields, improving conditions and resources for scientific work, and increasing international cooperation, in line with strategic objective 1: raising scientific excellence. The results of the project could provide pathophysiological insight into the development and maintenance of endothelial dysfunction in CKD, as well as identify new biomarkers for CKD.
Detailed description
The primary objective of this project is to determine the role of endothelial glycocalyx (eGC) in impaired microvascular endothelium-dependent reactivity in patients with chronic kidney disease compared to healthy and hypertensive patients without complications (cross-sectional study 1).
Specific objective 1.1: Measure the reactivity of the peripheral microcirculation (using a laser Doppler blood flow meter) and the thickness of eGC (using Glycocheck) in the specified groups.
Specific objective 1.2: Quantify soluble markers of eGC, oxidative stress, and inflammation from serum samples and peripheral blood mononuclear cells (PBMC), as well as antioxidant capacity in the specified groups.
Specific objective 1.3: Determine the relationship between the results of functional tests, eGC, and markers from specific objective 1.2.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease (CKD) group | – | –Patients with CKD of hypertensive etiology, stages 1-2 and 3-5 (eGFR CKD-EPI GFR ≥ 90 ml/min/1.73 m², i.e. < 60 mL/min/1.73 m2), non-diabetics, non-smokers |
| Hypertension (HT) group | – | –Patients who have hypertension (according to ESH2023 Guidelines doi: 10.1097/HJH.0000000000003480) without kidney damage (eGFR CKD-EPI >90 mL/min/1.73 m2) non-diabetics, non-smokers |
| Normotensive (NT) group | – | –Healthy volunteer subjects as controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CKD of hypertensive etiology, patients with hypertension and healthy volunteer subjects as controls.
Key inclusion criteria (3 listed)
- patients with CKD of hypertensive etiology (grades 1-2 and 3-5; eGFR CKD-EPI GFR ≥ 90 ml/min/1.73 m², i.e. < 60 mL/min/1.73 m2), non-diabetics, non-smokers
- patients with hypertension (according to ESH2023 Guidelines) without kidney damage (eGFR CKD-EPI >90 mL/min/1.73 m2) non-diabetics, non-smokers
- healthy volunteer subjects as controls
Key exclusion criteria (4 listed)
- kidney disease of any other etiology except hypertension
- endocrine, autoimmune or inflammatory diseases that could affect kidney function.
- smoking
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microvascular reactivity
Time frame: Baseline, at one time point (first visit to the laboratory)
Skin microvascular reactivity in patients with chronic kidney disease compared to hypertensive patients and healthy subjects - assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, acetylcholine and sodium nitroprusside)
Endothelial glycocalyx
Time frame: Baseline, at one time point (first visit to the laboratory)
Measurement of the thickness of eGC in the specified groups - measured by Glycocheck
4 secondary outcomes
Endothelial glycocalyx soluble markers
Time frame: Baseline, at one time point (first visit to the laboratory)
Concentration of MPO, 8-iso prostaglandin F2a, OxLDL, AOPP and intracellular oxidative stress production
Time frame: Baseline, at one time point (first visit to the laboratory)
Macrophage frequency
Time frame: Baseline, at one time point (first visit to the laboratory)
Antioxidant enzyme (SOD, CAT, GPx) concentration and activity
Time frame: Baseline, at one time point (first visit to the laboratory)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ines Drenjančević, MD, PhD study chair
Faculty of Medicine Josip Juraj Strossmayer University of Osijek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Patients, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ines Drenjančević, MD, PhD (+385912241406, ines.drenjancevic@mefos.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular reactivity (time frame: Baseline, at one time point (first visit to the laboratory)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.