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

Soroka University Medical Center

Status: Unknown

Conditions: Renal Failure Chronic Requiring Hemodialysis

Treatments: Drug: Iron Saccharate (Venofer)

Study type: Interventional

Funder types: Other

Identifiers

NCT00560976

sor419105ctil

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Iron Saccharate (Venofer)

Experimental group

Description:

IV Iron Saccharate (Venofer)100 mg

Treatment:

Drug: Iron Saccharate (Venofer)