Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03169400
Recruitment Status : Unknown
Verified May 2017 by Mario Cozzolino, University of Milan.
Recruitment status was:  Not yet recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Mario Cozzolino, University of Milan

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

Condition or disease Intervention/treatment
End Stage Renal Failure on Dialysis Vascular Calcification Oxidative Stress Device: Theranova dialyzer

  Show Detailed Description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 6 Months
Official Title: Molecular and Cellular Mechanism of Vascular Ageing in Chronic Kidney Disease: Role of Theranova Dialyzer on Mineral Metabolism Disorder, Oxidative Stress, and Vascular Calcification
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 Name: 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.



Primary Outcome Measures :
  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. [ Time Frame: 12 months ]
    Quantification of calcium into the cells


Secondary Outcome Measures :
  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. [ Time Frame: 12 months ]
    Oxidative stress into the cells



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Key Inclusion Criteria: ESRD on HD

Key Exclusion Criteria: cachexia; cancer


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169400


Contacts
Layout table for location contacts
Contact: Soncini Chiara, PhD 02503 23231 chiara.soncini@unimi.it

Locations
Layout table for location information
Italy
University of Milan Not yet recruiting
Milan, Italy, 20142
Contact: Mario Cozzolino, Md, PhD    00390281844215    mario.cozzolino@unimi.it   
Sponsors and Collaborators
University of Milan

Additional Information:

Layout table for additonal information
Responsible Party: Mario Cozzolino, Professor of Nephrology, MD, PhD, FERA, FASN, University of Milan
ClinicalTrials.gov Identifier: NCT03169400     History of Changes
Other Study ID Numbers: BXT-MI1
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mario Cozzolino, University of Milan:
vascular calcification
haemodialysis
dialysis membrane

Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Calcinosis
Kidney Failure, Chronic
Vascular Calcification
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases