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Evaluation Of A New Vitamin E-Bonded Membrane On Anemia And Oxidative Stress In End-Stage Renal Disease Patients (Vi-E)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00687258
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : April 11, 2012
Information provided by (Responsible Party):
Simeone Andrulli, A. Manzoni Hospital

Brief Summary:

The main purpose of this longitudinal study is to point out the effect of VitabranE on the ESA resistance and on the anemia observed in HD patients undergoing EPO maintenance therapy.

As a secondary purpose we will consider the effect of VitabranE on inflammation and oxidative stress parameters as a function of the changes observed in the anemia parameters.

Condition or disease Intervention/treatment Phase
Anemia Device: VitabranE ViE Device: APS-U (Asahi Polysulfone APS) Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation Of The Impact Of A New Synthetic Vitamin E-Bonded Membrane On The Anemia And Oxidative Stress In End-Stage Renal Disease (ESRD) Patients
Study Start Date : July 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : July 2007

Arm Intervention/treatment
Experimental: 1
Vitamin E-bonded polysulfone dialyzer
Device: VitabranE ViE
Polysulfone dialyser with vitamin E alpha-tocopherol
Other Name: Vitamin E-bonded polysulfone dialyzer

No Intervention: 2
Polysulfone dialyzer without vitamin E alpha-tocopherol
Device: APS-U (Asahi Polysulfone APS)
PS Polysulfone dialyser without vitamin E alpha-tocopherol
Other Name: Asahi Polysulfone APS

Primary Outcome Measures :
  1. The primary outcome measure will be the ESA resistance index, a combined variable calculated by dividing the weekly ESA dose by haemoglobin level and end-dialysis body weight. [ Time Frame: every other month ]

Secondary Outcome Measures :
  1. Inflammatory status (CRP and IL-6) and oxidative stress markers (Vitamin E levels, TAC, Protein carbonyls and AOPP, AGEs). [ Time Frame: every other month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female patients, aged ≥ 18, stabilized on BHD for at least 6 months.
  2. Clinical stability during the last 3 months.
  3. Serum Ferritin > 200 mg/L and Transferrin saturation >30%.
  4. Maintenance therapy with epoetin alfa/beta or darbepoetin alfa.

Exclusion Criteria:

  1. One of the following condition in the last 3 months :

    • acute infection
    • vascular access thrombosis
    • ictus cerebri
    • myocardial stroke
    • haemorrhage
    • major surgery
    • haemo-transfusion
  2. Haemoglobinopaty, sickle cell anemia, familial erythroblastic anemia and any other haematological disorder interfering with the aim of the study
  3. Malignancy
  4. Participation to other studies or use of EPO analogues not yet commercialized
  5. pharmacological dosage administration of antioxidant supplements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00687258

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Alessandro Manzoni Hospital, Nephrology and Dialysis Department
Lecco, Italy, 23900
Sponsors and Collaborators
A. Manzoni Hospital
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Principal Investigator: Francesco Locatelli, MD Nephrology and Dialysis Department - A. Manzoni Hospital

Publications of Results:
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Responsible Party: Simeone Andrulli, Simeone Andrulli, MD, A. Manzoni Hospital Identifier: NCT00687258     History of Changes
Other Study ID Numbers: Vit E-Rif01-1
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: April 11, 2012
Last Verified: April 2012

Keywords provided by Simeone Andrulli, A. Manzoni Hospital:
Oxidative Stress
dialyser membrane
Vitamin E
Erythropoietin responsiveness
Erythropoietin resistance

Additional relevant MeSH terms:
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Vitamin E
Kidney Diseases
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents