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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Soroka University Medical Center
Sponsor:
Information provided by (Responsible Party):
David Tovbin, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00560976
First received: November 18, 2007
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
Renal Failure Chronic Requiring Hemodialysis
Drug: Iron Saccharate (Venofer)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels in Hemodialysis (HD) Patients; Relation to Iron Status, Hemodialysis, and Intravenous (IV) Iron Administration

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Ferric gluconate (Ferrlecit)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560976

Contacts
Contact: David Tovbin, MD 972-54-296579 dtovbin@bgu.ac.il

Locations
Israel
Department of Nephrology, Soroka University Medical center Completed
Beer-Sheva, Israel, 84101
Bnai-zion Medical Center,Nephrology, Completed
Haifa, Israel
Department of Nephrology, Wolfson Medical Center Recruiting
Holon, Israel
Contact: Alexander Biro, MD    97235028285    abiro@wolfson.health.gov.il   
Contact: Katzir Zeev, MD    97235028291    Katzir@wolfson.health.gov.il   
Principal Investigator: Alexander Biro, MD         
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: David Tovbin, MD Soroka University Medical Center
  More Information

No publications provided

Responsible Party: David Tovbin, Dr David Tovbin, Department of Nephrology, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00560976     History of Changes
Other Study ID Numbers: sor419105ctil
Study First Received: November 18, 2007
Last Updated: April 17, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Soroka University Medical Center:
neutrophil gelatinase associated lipocalin
hemodialysis
iron
inflammation
Oxidative Stress

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Ferric gluconate
Ferric oxide, saccharated
Ferric Compounds
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014