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

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

Study Overview

• Status: Unknown
• Conditions: Renal Failure Chronic Requiring Hemodialysis
• Intervention / Treatment: Drug: Iron Saccharate (Venofer)

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Tovbin, MD; Phone Number: 972-54-296579; Email: dtovbin@bgu.ac.il

Study Locations

• Israel
  • Beer-Sheva, Israel, 84101
    • Completed
    • Department of Nephrology, Soroka University Medical center
  • Haifa, Israel
    • Completed
    • Bnai-zion Medical Center,Nephrology,
  • Holon, Israel
    • Recruiting
    • Department of Nephrology, Wolfson Medical Center
    • Contact: Alexander Biro, MD; Phone Number: 97235028285; Email: abiro@wolfson.health.gov.il
    • Contact: Katzir Zeev, MD; Phone Number: 97235028291; Email: Katzir@wolfson.health.gov.il
    • Principal Investigator: Alexander Biro, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron Saccharate (Venofer); IV Iron Saccharate (Venofer)100 mg	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).; Other Names: Ferric gluconate (Ferrlecit)

What is the study measuring?

Primary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Investigators: Principal Investigator: David Tovbin, MD, Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 18, 2007
• First Submitted That Met QC Criteria: November 19, 2007
• First Posted (Estimate): November 20, 2007

Study Record Updates

• Last Update Posted (Estimate): April 18, 2013
• Last Update Submitted That Met QC Criteria: April 17, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Oxidative Stress; inflammation; hemodialysis; iron; neutrophil gelatinase associated lipocalin
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hematinics; Ferric Oxide, Saccharated; Ferric gluconate
• Other Study ID Numbers: sor419105ctil