Theranova Dialyzer and Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD)
Molecular and Cellular Mechanism of Vascular Ageing in Chronic Kidney Disease: Role of Theranova Dialyzer on Mineral Metabolism Disorder, Oxidative Stress, and Vascular Calcification
1 other identifier
observational
20
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedMay 30, 2017
May 1, 2017
11 months
May 25, 2017
May 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Quantification of calcium into the cells
12 months
Secondary Outcomes (1)
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.
12 months
Study Arms (2)
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.
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.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Milan
Milan, 20142, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Nephrology, MD, PhD, FERA, FASN
Study Record Dates
First Submitted
May 25, 2017
First Posted
May 30, 2017
Study Start
October 1, 2017
Primary Completion
August 31, 2018
Study Completion
December 31, 2018
Last Updated
May 30, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share