Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gambro Lundia AB
ClinicalTrials.gov Identifier:
NCT01783626
First received: January 28, 2013
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities).

Materials(including heparin grafted specifications) as well as the sterilization process are identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with regards to protein loss.


Condition Intervention
End Stage Renal Disease (ESRD)
Device: Evodial
Device: Evodial+ Condition B1
Device: Evodial+ Condition B2
Device: Evodial+ Condition C

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +) - A Prospective, Monocenter, Open and Non-randomized Pilot Study

Resource links provided by NLM:


Further study details as provided by Gambro Lundia AB:

Primary Outcome Measures:
  • Efficacy: Beta 2 Microglobulin elimination [ Time Frame: Change from T0 (dialysis start) at T4 hours (dialysis stop) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: -Elimination of Myoglobin,alpha 1 Microglobulin, alpha amylase and Factor D [ Time Frame: Change from T0 (dialysis start) at T 4hours (dialysis stop) ] [ Designated as safety issue: No ]
  • Efficacy:Profile of ultrafiltrated proteins [ Time Frame: at T4 hours ] [ Designated as safety issue: No ]
  • Safety: Follow-up of all AEs/SAEs [ Time Frame: during the study period ] [ Designated as safety issue: Yes ]
  • Safety: Measurement of Albumin loss [ Time Frame: At T4 hours ] [ Designated as safety issue: Yes ]
  • Efficacy: Cumulative Purified volume (Kt) [ Time Frame: At T4 hours ] [ Designated as safety issue: No ]
  • Safety: Total protein [ Time Frame: Change from T0 and T4 hours ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Evodial
Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week)
Device: Evodial
Experimental: Evodial+ Condition B1
Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week)
Device: Evodial+ Condition B1
Experimental: Evodial+ Condition B2
Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week)
Device: Evodial+ Condition B2
Experimental: Evodial+ Condition C
Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week)
Device: Evodial+ Condition C

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Anuric patient (diuresis<300ml) ,
  2. ESRD patient treated for at least 3 months,
  3. Patient treated in HDF post-dilution,
  4. Vascular access functioning properly (Qb > 250 ml/min),
  5. Patient aged 18 years or more,
  6. Written consent to participate in the study (informed consent).

Exclusion Criteria:

  1. Patient with pre-dialytic albuminemia <3.3 g/dl(Nephelometry assay)
  2. Patient with known allergy to heparin or type II heparininduced thrombocytopenia (HIT type II);
  3. Patient under guardianship;
  4. Women pregnant or breast feeding;
  5. Patient included in other studies that could interfere with the goals of the current study.
  6. Patient that are not affiliated to the health system(beneficiary or dependent).
  7. Patient with positive serology (HIV, Hepatitis).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01783626

Locations
France
Hôpital Louis-Pasteur (Cherbourg-Octeville)
Cherbourg-Octeville, France, 50102
Sponsors and Collaborators
Gambro Lundia AB
Investigators
Study Director: Nathalie Loughraieb Gambro Industries
  More Information

No publications provided

Responsible Party: Gambro Lundia AB
ClinicalTrials.gov Identifier: NCT01783626     History of Changes
Other Study ID Numbers: 1498
Study First Received: January 28, 2013
Last Updated: April 22, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on July 26, 2014