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

Soroka University Medical Center100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Renal Failure Chronic Requiring Hemodialysis

Interventions

Iron Saccharate (Venofer)DRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 88 Years

Medical Language ↔ Plain English

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

Locations (3)

Department of Nephrology, Soroka University Medical center

Beersheba, Israel

COMPLETED

Bnai-zion Medical Center,Nephrology,

Haifa, Israel

COMPLETED

Department of Nephrology, Wolfson Medical Center

Holon, Israel

RECRUITING

Outcomes

Primary Outcomes

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.

Central Contacts

David Tovbin, MD

CONTACT

972-54-296579 dtovbin@bgu.ac.il

Data from ClinicalTrials.gov

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