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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00560976

Enrollment

100

Registered

2007-11-20

Start date

2005-12-31

Completion date

2014-12-31

Last updated

2013-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure Chronic Requiring Hemodialysis

Keywords

neutrophil gelatinase associated lipocalin, hemodialysis, iron, inflammation, Oxidative Stress

Brief summary

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

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.

Interventions

DRUGIron 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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 88 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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.

Countries

Israel

Contacts

Primary ContactDavid Tovbin, MD

dtovbin@bgu.ac.il972-54-296579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026