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

Primary Purpose

End Stage Renal Disease, Dialysis Related Complication, Dialysis Amyloidosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Theranova-500 dialyzer
Elisio-21H
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Renal Disease focused on measuring dialyzer, beta2-microglobilin, myoglobin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ).

Sites / Locations

  • CHU DE Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Theranova-500

Elisio-21H

Arm Description

Outcomes

Primary Outcome Measures

Removal of myoglobin
myoglobin Reduction ratio.

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2017
Last Updated
April 10, 2020
Sponsor
Poitiers University Hospital
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03211676
Brief Title
Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer
Acronym
THERANOVA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
Collaborators
Baxter Healthcare Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Dialysis Related Complication, Dialysis Amyloidosis
Keywords
dialyzer, beta2-microglobilin, myoglobin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Theranova-500
Arm Type
Active Comparator
Arm Title
Elisio-21H
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Theranova-500 dialyzer
Intervention Description
hemodialysis with Theranova-500 dialyzer.
Intervention Type
Device
Intervention Name(s)
Elisio-21H
Intervention Description
hemodialysis with Elisio-21H dialyzer
Primary Outcome Measure Information:
Title
Removal of myoglobin
Description
myoglobin Reduction ratio.
Time Frame
After 3 months
Secondary Outcome Measure Information:
Title
Removal of beta2 microglobulin
Description
Reduction rate and clearances of beta2 microglobulin
Time Frame
After 3 months
Title
Removal of urea
Description
Reduction ratio and clearances of urea
Time Frame
After 3 months
Title
Removal of creatinine
Description
Reduction ratio and clearances of creatinine
Time Frame
After 3 months
Title
Removal of interleukin 6
Description
Reduction ratio and clearances of interleukin 6
Time Frame
After 3 months
Title
Removal of IL-1beta
Description
Reduction ratio and clearances of IL-1beta
Time Frame
After 3 months
Title
Removal of TNF alpha
Description
Reduction ratio and clearances of TNF alpha
Time Frame
After 3 months
Title
Removal of leptin
Description
Reduction ratio and clearances of leptin
Time Frame
After 3 months
Title
Removal of alpha 1 microglobulin
Description
Reduction ratio and clearances of alpha 1 microglobulin
Time Frame
After 3 months
Title
Removal of retinol binding protein
Description
Reduction ratio and clearances of retinol binding protein
Time Frame
After 3 months
Title
Removal of hyaluronic acid
Description
Reduction ratio and clearances of hyaluronic acid
Time Frame
After 3 months
Title
Removal of FGF 23 (fibroblast growth factor 23)
Description
Reduction ratio and clearances of FGF 23
Time Frame
After 3 months
Title
Removal of prolactin
Description
Reduction ratio and clearances of prolactin
Time Frame
After 3 months
Title
Removal of free light chain kappa
Description
Reduction ratio and clearances of free light chain kappa
Time Frame
After 3 months
Title
Removal of free light chain lambda
Description
Reduction ratio and clearances of free light chain lambda
Time Frame
After 3 months
Title
comparison of pre dialysis level of hepcidin
Description
comparison of average of pre dialysis level of hepcidin
Time Frame
After 3 months
Title
comparison of pre dialysis level of superoxide dismutase
Description
comparison of average of pre dialysis level of superoxide dismutase
Time Frame
After 3 months
Title
comparison of pre dialysis level of isoprostan
Description
comparison of average of pre dialysis level of isoprostan
Time Frame
After 3 months
Title
comparison of pre dialysis level of human oxidized LDL
Description
comparison of average of pre dialysis level of human oxidized LDL
Time Frame
After 3 months
Title
comparison of pre dialysis level of albumin
Description
comparison of average of pre dialysis level of albumin
Time Frame
After 3 months
Title
comparison of pre dialysis level of prealbumin
Description
comparison of average of pre dialysis level of prealbumin
Time Frame
After 3 months
Title
comparison of post dialysis level of albumin
Description
comparison of average of post dialysis level of albumin
Time Frame
After 3 months
Title
comparison of level of middle molecules and albumin in the dialysate
Description
comparison of average level of midlle molecules and albumin in dialysate
Time Frame
After 3 months
Title
comparison of use of erythrpoietin
Description
Comparison of the erythropoietin resistance index
Time Frame
After 3 months
Title
comparison of hemoglobin levels
Description
comparison of average of predialysis hemoglobin levels
Time Frame
After 3 months
Title
comparison of pre dialysis level of CRP
Description
comparison of average of pre dialysis level of CRP
Time Frame
After 3 months
Title
comparison of pre dialysis level of SAA
Description
comparison of average of pre dialysis level of SAA
Time Frame
After 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed BELMOUAZ
Organizational Affiliation
Poitiers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU DE Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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