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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Simeone Andrulli, A. Manzoni Hospital
ClinicalTrials.gov Identifier:
NCT00687258
First received: May 6, 2008
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Anemia
 Device: VitabranE ViE
Device: APS-U (Asahi Polysulfone APS)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by A. Manzoni Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory status (CRP and IL-6) and oxidative stress markers (Vitamin E levels, TAC, Protein carbonyls and AOPP, AGEs). [ Time Frame: every other month ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2006
Study Completion Date: July 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687258

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

Publications:

Responsible Party: Simeone Andrulli, Simeone Andrulli, MD, A. Manzoni Hospital
ClinicalTrials.gov Identifier: NCT00687258     History of Changes
Other Study ID Numbers: Vit E-Rif01-1
Study First Received: May 6, 2008
Last Updated: April 10, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by A. Manzoni Hospital:
Anemia
Oxidative Stress
Erythropoietin
dialyser membrane
 Vitamin E
Erythropoietin responsiveness
Erythropoietin resistance
hemodialysis

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vitamin E
Alpha-Tocopherol
Tocopherols
 Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013