Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

End Stage Renal Disease (ESRD) Clinical Trial

Official title:

Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +) - A Prospective, Monocenter, Open and Non-randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783626
• Other study ID #: 1498
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: May 5, 2017
• Start date: October 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• End Stage Renal Disease (ESRD)
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Device:
• Evodial

• Evodial+ Condition B1

• Evodial+ Condition B2

• Evodial+ Condition C

Locations

Country	Name	City	State
France	Hôpital Louis-Pasteur (Cherbourg-Octeville)	Cherbourg-Octeville

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Lundia AB

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Beta 2 Microglobulin elimination		Change from T0 (dialysis start) at T4 hours (dialysis stop)
Secondary	Efficacy: -Elimination of Myoglobin,alpha 1 Microglobulin, alpha amylase and Factor D		Change from T0 (dialysis start) at T 4hours (dialysis stop)
Secondary	Efficacy:Profile of ultrafiltrated proteins		at T4 hours
Secondary	Safety: Follow-up of all AEs/SAEs		during the study period
Secondary	Safety: Measurement of Albumin loss		At T4 hours
Secondary	Efficacy: Cumulative Purified volume (Kt)		At T4 hours
Secondary	Safety: Total protein		Change from T0 and T4 hours