Clinical Trials Logo

Clinical Trial Summary

The project will be structured in 3 main parts:

1. Effect of sera of ESRD patients on HD using Theranova dialyzer on high-Pi induced vascular calcification in an in vitro model of rat VSMCs.

2. Effect of sera of ESRD patients on HD using Theranova dialyzer on oxidative stress pathways in an in vitro model of rat VSMCs vascular calcification.

3. Study of RNA sequencing, transcriptome analysis gene expression of time course high-P challenged VSMCs studying the effect of sera of ESRD patients on HD using Theranova dialyzer


Clinical Trial Description

Ageing is a potent, independent risk factor for cardiovascular (CV) disease and the calcification of the vascular smooth muscle cell (VSMC) layer of the vessel media, typical of Monckenberg syndrome, is a hallmark of vascular ageing. Young patients with chronic kidney disease (CKD) exhibit an extremely high CV mortality, equivalent to that seen in octogenarians in the general population. Even children on dialysis develop accelerated medial vascular calcification (VC) and arterial stiffening, leading to the suggestion that patients with CKD exhibit a 'premature ageing' phenotype. It is now well documented that uraemic toxins, particularly those associated with dysregulated mineral metabolism, can drive VSMC damage and phenotypic changes that promote VC, and epidemiological data suggest that some of these same risk factors associate with CV mortality in the aged general population.

VC is common in CKD and associated with increased morbidity and mortality. Its mechanism is multifactorial and incompletely understood. CKD patients are at risk for VC because of multiple risk factors that induce VSMCs to change into a osteoblast-like cell such as high total body burden of calcium (Ca) and phosphorus (P) due to abnormal bone metabolism, low levels of circulating and locally produced inhibitors, impaired renal excretion, and current therapies. Together these factors increase risk and complicate the management of VC. Cells with unexpected osteoblastic potential may abnormally lay down some forms of VC, especially in the arterial wall of blood vessels. The pathogenesis of VC is likely a hybrid process of tightly regulated normal bone modeling and the purely physicochemical deposition of mineral.

The interest in VC in CKD patients has several reasons. First, it is now clear that in the general population the calcification of both intimal atherosclerotic lesions and the medial vessel layer are associated with CV morbidity and mortality. Similar, some data also exists for stage 5 CKD. Second, there is now better evidence that VSMCs can become osteoblast-like and lay down and mineralize collagen and noncollagenous proteins in arteries. Third, over 20 null mutations in mice have VC confirming that key proteins regulate or prevent VC. Fourth, there is increasing recognition of a link between CKD and bone and VC in the general population. Lastly, we now know some of our well-intended interventions to treat renal osteodystrophy accelerate arterial calcification.

CKD patients have an increased CV risk factor due to the impaired renal function induced by the pathology. More than 90% of CKD patients die for CV events with a main role of VC. One of the VC inducer is HD per se. Since the choice of dialyzer may play a role on prevalence of CV complication in CKD, the aim of this project will be to elucidate the effect of Theranova dialyzer on delay VC progression.

The project will be structured in 3 main parts:

1. Effect of sera of ESRD patients on HD using Theranova dialyzer on high-Pi induced vascular calcification in an in vitro model of rat VSMCs.

2. Effect of sera of ESRD patients on HD using Theranova dialyzer on oxidative stress pathways in an in vitro model of rat VSMCs vascular calcification.

3. Study of RNA sequencing, transcriptome analysis gene expression of time course high-P challenged VSMCs studying the effect of sera of ESRD patients on HD using Theranova dialyzer Primary Endpoint: Effect of sera of ESRD patients on HD using Theranova dialyzer on high-Pi induced vascular calcification in an in vitro model of rat VSMCs.

Secondary Endpoints: Effect of sera of ESRD patients on HD using Theranova dialyzer on oxidative stress pathways in an in vitro model of rat VSMCs vascular calcification.

Study of RNA sequencing, transcriptome analysis gene expression of time course high-P challenged VSMCs studying the effect of sera of ESRD patients on HD using Theranova dialyzer ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03169400
Study type Observational [Patient Registry]
Source University of Milan
Contact Soncini Chiara, PhD
Phone 02503 23231
Email chiara.soncini@unimi.it
Status Not yet recruiting
Phase N/A
Start date October 1, 2017
Completion date December 31, 2018

See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04136821 - The Long-term Effects of Oceanix™ on Resistance Training Adaptations N/A
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Completed NCT03358524 - Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia Phase 4
Recruiting NCT05327348 - Effectiveness of IV Vitamin C in Reducing Oxidative Stress Associated With Free Flap Surgery Phase 3
Completed NCT03288623 - The Effects of Dark Chocolate Implementation in Elite Athletes N/A
Completed NCT04419025 - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease Phase 2
Completed NCT04597983 - Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A
Enrolling by invitation NCT03030456 - Whole Body Vibrations on Functional Capacity, Muscular Strength, and Biochemical Profile in Elders N/A
Completed NCT02256254 - SIMOX - Induction of Oxidative Stress Phase 2
Not yet recruiting NCT02202239 - Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients Phase 4
Recruiting NCT02048592 - Impact of Immunonutrition on the Patients With Cystic Fibrosis Phase 4
Completed NCT01942460 - Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients Phase 4
Completed NCT02463318 - The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects N/A
Completed NCT02177383 - Action of Essential Fatty Acids on the Expression of Antioxidant Genes and Athletic Performance N/A
Completed NCT01990391 - Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities N/A
Completed NCT00845130 - Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes N/A
Completed NCT00607893 - Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea N/A
Active, not recruiting NCT00247507 - The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients Phase 4