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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official 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

Conditions
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Renal Failure Chronic Requiring Hemodialysis

Intervention / Treatment
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* Drug: Iron Saccharate (Venofer)


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron Saccharate (Venofer)<br>IV Iron Saccharate (Venofer)100 mg | Drug: Iron Saccharate (Venofer)<br>* 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).<br>* Other names: Ferric gluconate (Ferrlecit);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP (C-Reactive Protein) and AOPP (Advanced Oxidative Protein Products) Levels |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neutrophil gelatinase associated lipocalin, hemodialysis, iron, inflammation, Oxidative Stress