NCT00560976

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

9 years

First QC Date

November 18, 2007

Last Update Submit

April 17, 2013

Conditions

Renal Failure Chronic Requiring Hemodialysis

Keywords

neutrophil gelatinase associated lipocalinhemodialysisironinflammationOxidative Stress

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Iron Saccharate (Venofer)

EXPERIMENTAL

IV Iron Saccharate (Venofer)100 mg

Drug: Iron Saccharate (Venofer)

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).

Also known as: Ferric gluconate (Ferrlecit)
Iron Saccharate (Venofer)

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic hemodialysis patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Nephrology, Soroka University Medical center

Beersheba, 84101, Israel

COMPLETED

Bnai-zion Medical Center,Nephrology,

Haifa, Israel

COMPLETED

Department of Nephrology, Wolfson Medical Center

Holon, Israel

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Ferric Oxide, Saccharatedferric gluconate

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • David Tovbin, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Tovbin, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr David Tovbin, Department of Nephrology

Study Record Dates

First Submitted

November 18, 2007

First Posted

November 20, 2007

Study Start

December 1, 2005

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations

IL(3)