miRNA in Chronic Kidney Diseases

NCT06316284 | Not Yet Recruiting

• 1 other identifier: miRNA-CKD
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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)

  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).

  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.

  Day 1

Secondary Outcomes (1)

• Body fluid compartments

  at one time point

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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)

You may not qualify if:

• cardiovascular diseases, but hypertension
• diabetes
• cerebrovascular diseases
• peripheral artery disease

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead
• University Hospital Center Osijek: collaborator

Study Sites (1)

Faculty of Medicine Osijek

Osijek, 31000, Croatia

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, peripheral blood mononuclear cells (PBMCs)

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ines Drenjančević, MD, PhD

CONTACT

+38531512800; ines.drenjancevic@mefos.hr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Dean for Science Faculty of Medicine Osijek

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 18, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)