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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 April 2013 |
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Main ID: |
NCT00560976 |
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Date of registration:
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18/11/2007 |
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Primary sponsor: |
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Public title:
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Serum NGAL Levels in Hemodialysis (HD) Patients; Relation to Iron Status, HD and Intravenous (IV) Iron Administration
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Scientific title:
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Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels in Hemodialysis (HD) Patients; Relation to Iron Status, Hemodialysis, and Intravenous (IV) Iron Administration |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00560976 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Israel
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Contacts
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Name:
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Alexander Biro, MD |
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Address:
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Telephone:
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97235028285 |
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Email:
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abiro@wolfson.health.gov.il |
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Affiliation:
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Name:
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David Tovbin, MD |
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Address:
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Telephone:
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972-54-296579 |
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Email:
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dtovbin@bgu.ac.il |
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Affiliation:
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Name:
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David Tovbin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Soroka University Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Chronic hemodialysis patients
Exclusion Criteria:
- Acute disease (infection, thrombosis, ischemia, bleeding)
- Hepatitis B, Hepatitis C or HIV
- Intravenous iron administration or packed red cell transfusion in the last 4 weeks
prior to the study
Age minimum:
18 Years
Age maximum:
88 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Failure Chronic Requiring Hemodialysis
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Intervention(s)
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Drug: Iron Saccharate (Venofer)
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Primary Outcome(s)
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CRP (C-Reactive Protein) and AOPP (Advanced Oxidative Protein Products) Levels
[Time Frame: To assess the effects of 100 mg IV iron in the first hour of the first weekly HD on the relation of pre IV iron serum NGAL levels with oxidative stress and inflammation related parameters.]
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Secondary ID(s)
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sor419105ctil
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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