Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer (THERANOVA)

April 10, 2020 updated by: Poitiers University Hospital

Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer on Removal of Small and Middle Size Molecules, Inflammatory Parameters and Oxidative Stress. An Open Cross Over Randomized Study

The aim of this study is to evaluate the removal of midle molecules and inflammatory cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis.

Evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also be carried out.

Finally, the investigators will compare hepcidin levels and the erythropoietin resistance index between the two groups.

Study Overview

Status

Status

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

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.

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.
Interventional

Enrollment (Actual)

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.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Poitiers, France, 86021
        • CHU De Poitiers

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patient suffering from chronic terminal renal failure excluding nephropathy with myelomatous cylinders, hemodialysis for more than 6 months,
  • Patient under dialyser Elisio-21H ™ for more than 3 months
  • Patient including the protocol scheme and able to comply with it
  • Free subject, without guardianship or curatorship or subordination
  • Patients benefiting from a Social Security scheme or benefiting from it through a third party
  • Non-opposition given by the patient after clear and fair information on the study

Exclusion Criteria:

  • Age <18 years
  • Patient with an associated pathology (evolutionary cancer, progressive infectious disease or chronic inflammatory disease) that may excessively influence CRP levels (CRP> 60 mg / L)
  • Patient following another protocol of research or period of exclusion of another protocol
  • Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
  • Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies .
  • Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy ).

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: Theranova-500
Device: Theranova-500 dialyzer
hemodialysis with Theranova-500 dialyzer.
Device: Elisio-21H
hemodialysis with Elisio-21H dialyzer
Sham Comparator: Elisio-21H
Device: Theranova-500 dialyzer
hemodialysis with Theranova-500 dialyzer.
Device: Elisio-21H
hemodialysis with Elisio-21H dialyzer

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
Removal of myoglobin
Time Frame: After 3 months
myoglobin Reduction ratio.
After 3 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
Removal of beta2 microglobulin
Time Frame: After 3 months
Reduction rate and clearances of beta2 microglobulin
After 3 months
Removal of urea
Time Frame: After 3 months
Reduction ratio and clearances of urea
After 3 months
Removal of creatinine
Time Frame: After 3 months
Reduction ratio and clearances of creatinine
After 3 months
Removal of interleukin 6
Time Frame: After 3 months
Reduction ratio and clearances of interleukin 6
After 3 months
Removal of IL-1beta
Time Frame: After 3 months
Reduction ratio and clearances of IL-1beta
After 3 months
Removal of TNF alpha
Time Frame: After 3 months
Reduction ratio and clearances of TNF alpha
After 3 months
Removal of leptin
Time Frame: After 3 months
Reduction ratio and clearances of leptin
After 3 months
Removal of alpha 1 microglobulin
Time Frame: After 3 months
Reduction ratio and clearances of alpha 1 microglobulin
After 3 months
Removal of retinol binding protein
Time Frame: After 3 months
Reduction ratio and clearances of retinol binding protein
After 3 months
Removal of hyaluronic acid
Time Frame: After 3 months
Reduction ratio and clearances of hyaluronic acid
After 3 months
Removal of FGF 23 (fibroblast growth factor 23)
Time Frame: After 3 months
Reduction ratio and clearances of FGF 23
After 3 months
Removal of prolactin
Time Frame: After 3 months
Reduction ratio and clearances of prolactin
After 3 months
Removal of free light chain kappa
Time Frame: After 3 months
Reduction ratio and clearances of free light chain kappa
After 3 months
Removal of free light chain lambda
Time Frame: After 3 months
Reduction ratio and clearances of free light chain lambda
After 3 months
comparison of pre dialysis level of hepcidin
Time Frame: After 3 months
comparison of average of pre dialysis level of hepcidin
After 3 months
comparison of pre dialysis level of superoxide dismutase
Time Frame: After 3 months
comparison of average of pre dialysis level of superoxide dismutase
After 3 months
comparison of pre dialysis level of isoprostan
Time Frame: After 3 months
comparison of average of pre dialysis level of isoprostan
After 3 months
comparison of pre dialysis level of human oxidized LDL
Time Frame: After 3 months
comparison of average of pre dialysis level of human oxidized LDL
After 3 months
comparison of pre dialysis level of albumin
Time Frame: After 3 months
comparison of average of pre dialysis level of albumin
After 3 months
comparison of pre dialysis level of prealbumin
Time Frame: After 3 months
comparison of average of pre dialysis level of prealbumin
After 3 months
comparison of post dialysis level of albumin
Time Frame: After 3 months
comparison of average of post dialysis level of albumin
After 3 months
comparison of level of middle molecules and albumin in the dialysate
Time Frame: After 3 months
comparison of average level of midlle molecules and albumin in dialysate
After 3 months
comparison of use of erythrpoietin
Time Frame: After 3 months
Comparison of the erythropoietin resistance index
After 3 months
comparison of hemoglobin levels
Time Frame: After 3 months
comparison of average of predialysis hemoglobin levels
After 3 months
comparison of pre dialysis level of CRP
Time Frame: After 3 months
comparison of average of pre dialysis level of CRP
After 3 months
comparison of pre dialysis level of SAA
Time Frame: After 3 months
comparison of average of pre dialysis level of SAA
After 3 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.
Poitiers University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxter Healthcare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed BELMOUAZ, Poitiers University Hospital

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 (Actual)

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.
June 7, 2017

Primary Completion (Actual)

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.
March 14, 2018

Study Completion (Actual)

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.
June 14, 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 18, 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.
July 6, 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.
July 7, 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.
April 13, 2020

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.
April 10, 2020

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.
April 1, 2020

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.
  • 2016-A01679-42

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

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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