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

Not Applicable

• Conditions: Renal Failure Chronic Requiring Hemodialysis
• Interventions: Drug: Iron Saccharate (Venofer)

• Registration Number: NCT00560976
• Lead Sponsor: Soroka University Medical Center

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-11-18
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-17
• Last Update Posted: 2013-04-18
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iron Saccharate (Venofer)	Iron Saccharate (Venofer)	IV Iron Saccharate (Venofer)100 mg

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Department of Nephrology, Wolfson Medical Center; 🇮🇱 Holon, Israel

Department of Nephrology, Soroka University Medical center; 🇮🇱 Beer-Sheva, Israel

Bnai-zion Medical Center,Nephrology,; 🇮🇱 Haifa, Israel