NCT03211676

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

June 7, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2018

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

May 18, 2017

Last Update Submit

April 10, 2020

Conditions

End Stage Renal DiseaseDialysis Related ComplicationDialysis Amyloidosis

Keywords

dialyzerbeta2-microglobilinmyoglobin

Outcome Measures

Primary Outcomes (1)

  • Removal of myoglobin

    myoglobin Reduction ratio.

    After 3 months

Secondary Outcomes (26)

  • Removal of beta2 microglobulin

    After 3 months

  • Removal of urea

    After 3 months

  • Removal of creatinine

    After 3 months

  • Removal of interleukin 6

    After 3 months

  • Removal of IL-1beta

    After 3 months

  • +21 more secondary outcomes

Study Arms (2)

Theranova-500

ACTIVE COMPARATOR
Device: Theranova-500 dialyzerDevice: Elisio-21H

Elisio-21H

SHAM COMPARATOR
Device: Theranova-500 dialyzerDevice: Elisio-21H

Interventions

Theranova-500 dialyzerDEVICE

hemodialysis with Theranova-500 dialyzer.

Elisio-21HTheranova-500
Elisio-21HDEVICE

hemodialysis with Elisio-21H dialyzer

Elisio-21HTheranova-500

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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 ).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU DE Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed BELMOUAZ

    Poitiers University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2017

First Posted

July 7, 2017

Study Start

June 7, 2017

Primary Completion

March 14, 2018

Study Completion

June 14, 2018

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)