miRNA in Chronic Kidney Diseases

Chronic Kidney Diseases Clinical Trial

Official title:

The Role of miRNAs in the Regulation of Oxidative Stress and Microvascular Reactivity in Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06316284
• Other study ID #: miRNA-CKD
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Josip Juraj Strossmayer University of Osijek
• Contact: Ines Drenjancevic, MD, PhD
• Phone: +38531512800
• Email: ines.drenjancevic[@]mefos.hr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• cardiovascular diseases, but hypertension

• diabetes

• cerebrovascular diseases

• peripheral artery disease

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Croatia	Faculty of Medicine Osijek	Osijek

Sponsors (2)

Lead Sponsor	Collaborator
Josip Juraj Strossmayer University of Osijek	University Hospital Center Osijek

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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).	at one time point