Theranova Dialyzer and Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD)

May 26, 2017 updated by: Mario Cozzolino, University of Milan

Molecular and Cellular Mechanism of Vascular Ageing in Chronic Kidney Disease: Role of Theranova Dialyzer on Mineral Metabolism Disorder, Oxidative Stress, and Vascular Calcification

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Milan, Italy, 20142
        • University of Milan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

20 patients

Number of study or comparison groups: cross-over study; from HD patients treated with regular bicarbonate dialysis membrane (baseline). Then, patients will be treated for 3 months with Theranove dialyzer, and sera will be collected at 1, 2, and 3 months. We will create a serum pool.

Description

Key Inclusion Criteria: ESRD on HD

Key Exclusion Criteria: cachexia; cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Theranova treated
We will collect pool of human sera from HD patients treated with regular bicarbonate dialysis membrane (baseline). Then, patients will be treated for 3 months with Theranove dialyzer, and sera will be collected at 1, 2, and 3 months. We will create a serum pool.
Device: Theranova dialyzer
Hemoadialysis
Other Names:
  • Theranova
Standard treated
We will collect pool of human sera from HD patients treated with regular bicarbonate dialysis membrane (baseline). Then, patients will be treated for 3 months with Theranove dialyzer, and sera will be collected at 1, 2, and 3 months. We will create a serum pool.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
Quantification of calcium into the cells
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
Oxidative stress into the cells
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BXT-MI1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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