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

Renal Failure Chronic Requiring Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00560976
• Other study ID #: sor419105ctil
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2007
• Last updated: April 17, 2013
• Start date: December 2005
• Est. completion date: December 2014

Study information

• Verified date: April 2013
• Source: Soroka University Medical Center
• Contact: David Tovbin, MD
• Phone: 972-54-296579
• Email: dtovbin[@]bgu.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis

Intervention

Drug:
• Iron 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).

Locations

Country	Name	City	State
Israel	Department of Nephrology, Soroka University Medical center	Beer-Sheva
Israel	Bnai-zion Medical Center,Nephrology,	Haifa
Israel	Department of Nephrology, Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No