Serum NGAL Levels in Hemodialysis (HD) Patients; Relation to Iron Status, HD and Intravenous (IV) Iron Administration

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Soroka University Medical Center
Sponsor:
Information provided by (Responsible Party):
David Tovbin, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00560976
First received: November 18, 2007
Last updated: April 17, 2013
Last verified: April 2013

November 18, 2007
April 17, 2013
December 2005
December 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Serum NGAL levels [ Time Frame: Basal levels and changes induced by dialysis without and with intravenous (IV) iron administration ]
Complete list of historical versions of study NCT00560976 on ClinicalTrials.gov Archive Site
Not Provided
Relation of serum NGAL levels and changes in this parameter to seum iron, transferrin saturation, ferritin, c-reactive protein and Il-6 levels [ Time Frame: Relation of serum NGAL levels to the above parameters at baseline and following dialysis without and with IV iron administration ]
Not Provided
Not Provided
 
Serum NGAL Levels in Hemodialysis (HD) Patients; Relation to Iron Status, HD and Intravenous (IV) Iron Administration
Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels in Hemodialysis (HD) Patients; Relation to Iron Status, Hemodialysis, and Intravenous (IV) Iron Administration

The purpose of this study is to assess changes in serum levels of the siderophore binding protein NGAL by hemodialysis without and with intravenous iron administration

Serum and urine levels of the siderophore binding protein neutrophil gelatinase associated lipocalin (NGAL) are increased in a number of renal diseases, but has not been evaluated yet in dialysis patients. Since NGAL is suggested to be related to inflammatory processes and iron homeostasis, which are a major problem in dialysis patients, this study aims to assess the relation of serum NGAL levels in hemodialysis (HD) patients to iron status, inflammation, hemodialysis and intravenous(IV) iron administration. Our hypothesis is that serum NGAL levels in HD patients are related to iron status and inflammation and may change following hemodialysis and/or acute or chronic IV iron administration.

The Specific aims are:

  1. To assess the relations between basal serum NGAL levels to iron, dialysis, and inflammation related parameters.
  2. To assess the effect of HD on serum NGAL levels and their relation with with iron, dialysis and inflammation related parameters.
  3. To assess the effects of weekly 100 mg IV iron in the first hour of HD on serum NGAL levels, and the relation of pre IV iron serum NGAL levels with iron, oxidative stress and inflammation related parameters. These assessments will be performed in the first weekly HD.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Failure Chronic Requiring Hemodialysis
Drug: Iron Saccharate (Venofer)
Hemodialysis with IV iron administration of 100 mg Iron Saccharate (Venofer) in 150 ml 0.9 % saline to the arterial dialysis line during first hour of mid-week dialysis session. An alternative IV iron brand in some centers participating in the study could bebe 62.5 mg ferric gluconate (Ferrlecit).
Other Name: Ferric gluconate (Ferrlecit)
Experimental: Iron Saccharate (Venofer)
IV Iron Saccharate (Venofer)100 mg
Intervention: Drug: Iron Saccharate (Venofer)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 88 Years
No
Contact: David Tovbin, MD 972-54-296579 dtovbin@bgu.ac.il
Israel
 
NCT00560976
sor419105ctil
No
David Tovbin, Soroka University Medical Center
Soroka University Medical Center
Not Provided
Principal Investigator: David Tovbin, MD Soroka University Medical Center
Soroka University Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP