Serum NGAL Levels in Hemodialysis (HD) Patients; Relation to Iron Status, HD 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
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels in Hemodialysis (HD) Patients; Relation to Iron Status, Hemodialysis, and Intravenous (IV) Iron Administration|
- 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 ]
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Iron Saccharate (Venofer)
IV Iron Saccharate (Venofer)100 mg
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)
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:
- To assess the relations between basal serum NGAL levels to iron, dialysis, and inflammation related parameters.
- To assess the effect of HD on serum NGAL levels and their relation with with iron, dialysis and inflammation related parameters.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560976
|Contact: David Tovbin, MDfirstname.lastname@example.org|
|Department of Nephrology, Soroka University Medical center||Completed|
|Beer-Sheva, Israel, 84101|
|Bnai-zion Medical Center,Nephrology,||Completed|
|Department of Nephrology, Wolfson Medical Center||Recruiting|
|Contact: Alexander Biro, MD 97235028285 email@example.com|
|Contact: Katzir Zeev, MD 97235028291 Katzir@wolfson.health.gov.il|
|Principal Investigator: Alexander Biro, MD|
|Principal Investigator:||David Tovbin, MD||Soroka University Medical Center|