Chronic Kidney DiseasesNCT06316284
miRNA in Chronic Kidney Diseases
An observational study of Chronic Kidney Diseases, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
Oxidative stress and endoplasmic reticulum (ER) stress play a key role in tubular damage in both acute kidney injury and chronic kidney disease (CKD). Oxidative stress in the kidneys promotes renal vascular remodeling and increases preglomerular resistance. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 90 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2024to 31 Dec 2026
- 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 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with CKD and healthy controls, i.e. patients with hypertension without kidney damage (eGFR CKD-EPI > 90 mL/min/1.73 m2). Subjects and controls will be age- and gender-matched. Inclusion criteria for patients with CKD: the study will include patients having chronic kidney disease of the 3rd - 5th degree (eGFR CKD-EPI< 60 mL/min/1.73 m2).
Who may be able to join
- healthy normotensive adults (eGFR CKD-EPI >90 mL/min/1.73 m2, BP <140/90 mmHg)
- hypertensive adults (eGFR CKD-EPI >90 mL/min/1.73 m2, BP >140/90 mmHg)
- patients with chronic kidney disease stage 3-5 (eGFR CKD-EPI< 60 mL/min/1.73 m2)
Who cannot join
- cardiovascular diseases, but hypertension
- diabetes
- cerebrovascular diseases
- peripheral artery disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Role of miRNAs in the Regulation of Oxidative Stress and Microvascular Reactivity in Chronic Kidney Disease
Oxidative stress and endoplasmic reticulum (ER) stress play a key role in tubular damage in both acute kidney injury and chronic kidney disease (CKD). Oxidative stress in the kidneys promotes renal vascular remodeling and increases preglomerular resistance. These are key elements in hypertension, acute and chronic kidney injury, as well as diabetic nephropathy. Chronic renal hypoxia is highlighted as the final common pathway to end-stage renal disease (ESRD). MicroRNA molecules (miRNA) also play an important role in these processes. MicroRNAs (miRNAs) are regulators of gene expression and play a role in the progression of renal ischemia-reperfusion injury. Although the pathophysiological contribution of microRNAs (miRNAs) to kidney damage has also been highlighted, the effect of miRNAs on kidney damage under conditions of oxidative and ER stress remains understudied.
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney diseases, miRNA, oxidative stress, hypertension
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
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 group | Patients with stage 3-5 CKD (eGFR CKD-EPI <60 mL/min/1.73 m2) | |
| Healthy controls | Healthy normotensive patients (eGFR CKD-EPI >90 mL/min/1.73 m2, BP <140/90 mmHg) | |
| Hypertensive Group | Hypertensive patients without CKD (eGFR CKD-EPI >90 mL/min/1.73 m2, BP >140/90 mmHg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic microvascular function
Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside) - measured in perfusion units (PU)
Measured: Day 1
Serum level of antixidant enzymesprotein concentration of SOD, CAT and glutathione-peroxidase
Serum protein concentration of superoxide disimutase (SOD), catalase (CAT) and glutathione-peroxidase (GPx).
Measured: Day 1
Detecton of miRNA of interest
The database for miRNA will be searched, and the miRNA of interest will be selected, determined and detected.
Measured: Day 1
Secondary outcomes (1)
Body fluid compartments
Total body water (L), extracellular water (L), intracellular water (L) and plasma fluid volume (L) will be assessed using non-invasive bioimpedance analysis (BIA).
Measured: at one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Center Osijek
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316284
- Sponsor's protocol ID
- miRNA-CKD
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- 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 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of miRNAs in the Regulation of Oxidative Stress and Microvascular Reactivity in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06316284
- Acronym / sponsor ID
- miRNA-CKD
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney diseases, miRNA, oxidative stress, hypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Collaborators
- University Hospital Center Osijek
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Mar 2024 (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.
Oxidative stress and endoplasmic reticulum (ER) stress play a key role in tubular damage in both acute kidney injury and chronic kidney disease (CKD). Oxidative stress in the kidneys promotes renal vascular remodeling and increases preglomerular resistance. These are key elements in hypertension, acute and chronic kidney injury, as well as diabetic nephropathy. Chronic renal hypoxia is highlighted as the final common pathway to end-stage renal disease (ESRD). MicroRNA molecules (miRNA) also play an important role in these processes. MicroRNAs (miRNAs) are regulators of gene expression and play a role in the progression of renal ischemia-reperfusion injury. Although the pathophysiological contribution of microRNAs (miRNAs) to kidney damage has also been highlighted, the effect of miRNAs on kidney damage under conditions of oxidative and ER stress remains understudied.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease group | – | –Patients with stage 3-5 CKD (eGFR CKD-EPI <60 mL/min/1.73 m2) |
| Healthy controls | – | –Healthy normotensive patients (eGFR CKD-EPI >90 mL/min/1.73 m2, BP <140/90 mmHg) |
| Hypertensive Group | – | –Hypertensive patients without CKD (eGFR CKD-EPI >90 mL/min/1.73 m2, BP >140/90 mmHg) |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CKD and healthy controls, i.e. patients with hypertension without kidney damage (eGFR CKD-EPI > 90 mL/min/1.73 m2). Subjects and controls will be age- and gender-matched. Inclusion criteria for patients with CKD: the study will include patients having chronic kidney disease of the 3rd - 5th degree (eGFR CKD-EPI< 60 mL/min/1.73 m2).
Key inclusion criteria (3 listed)
- healthy normotensive adults (eGFR CKD-EPI >90 mL/min/1.73 m2, BP <140/90 mmHg)
- hypertensive adults (eGFR CKD-EPI >90 mL/min/1.73 m2, BP >140/90 mmHg)
- patients with chronic kidney disease stage 3-5 (eGFR CKD-EPI< 60 mL/min/1.73 m2)
Key exclusion criteria (4 listed)
- cardiovascular diseases, but hypertension
- diabetes
- cerebrovascular diseases
- peripheral artery disease
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
Systemic microvascular function
Time frame: Day 1
Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside) - measured in perfusion units (PU)
Serum level of antixidant enzymesprotein concentration of SOD, CAT and glutathione-peroxidase
Time frame: Day 1
Serum protein concentration of superoxide disimutase (SOD), catalase (CAT) and glutathione-peroxidase (GPx).
Detecton of miRNA of interest
Time frame: Day 1
The database for miRNA will be searched, and the miRNA of interest will be selected, determined and detected.
1 secondary outcome
Body fluid compartments
Time frame: at one time point
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 18 Mar 2024.
- 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.
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 Diseases, 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: opening soon, as of the sponsor's last update on 18 Mar 2024. 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 (+38531512800, ines.drenjancevic@mefos.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic microvascular function (time frame: Day 1). The study lists 3 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 18 Mar 2024.