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NCT Number: NCT06316284

miRNA in Chronic Kidney Diseases

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.

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Key information

Conditions

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

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Osijek

Osijek, 31000, Croatia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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).

  3. 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.

Secondary outcomes

  1. Body fluid compartments

    Time frame: at one time point

    Total body water (L), extracellular water (L), intracellular water (L) and plasma fluid volume (L) will be assessed using non-invasive bioimpedance analysis (BIA).

Study contacts

Contact information is provided by the study sponsor or research team.

Ines Drenjančević, MD, PhD

CONTACT

[email protected]

+38531512800

Sponsors and collaborators

Lead sponsor

Josip Juraj Strossmayer University of Osijek

Other

Collaborators

  • University Hospital Center Osijek

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 18, 2024
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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