Removal of Ligand-bound Iron During Intravenous (IV) Iron Administration in Hemodialysis (HD)

This study has been completed.
Sponsor:
Collaborators:
Bnai Zion Medical Center
Rivka Ziv Medical Center
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00638300
First received: March 12, 2008
Last updated: July 11, 2010
Last verified: March 2008
  Purpose

The study's hypothesis is that HD with large pore dialyzers remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.


Condition Intervention
Hemodialysis Patients
Device: large pore (FX80) compared to small pore dialyzer (F8HPS)
Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L
Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Removal of Ligand-bound Iron During Intravenous Iron Administration in Hemodialysis by Large Pore Dialyzers

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • 1. Dialysate Iron levels 2. Plasma levels of advanced oxidation protein products(AOPP) [ Time Frame: Before HD, after 1 hour of HD with or without IV iron and at end of HD ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: March 2008
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
large pore dialyzers (FX80, Fresenius, Germany)
Device: large pore (FX80) compared to small pore dialyzer (F8HPS)
Effect of pore size
Experimental: 2
small pore dialyzers ( F8HPS, Fresenius, Germany)
Device: large pore (FX80) compared to small pore dialyzer (F8HPS)
Effect of pore size
Experimental: A
dialysate bicarbonate concentration of 33 mEq/l
Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L
Effect of dialysate bicarbonate concentration
Experimental: B
dialysate bicarbonate concentration of 40 mEq/l
Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L
Effect of dialysate bicarbonate concentration
Experimental: I
dialysate calcium concentration of 3 mEq/L
Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L
Effect of dialysate calcium concentration
Experimental: II
dialysate calcium concentration of 2.5 mEq/L
Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L
Effect of dialysate calcium concentration

Detailed Description:

Most hemodialysis(HD) patients receive during HD intravenous iron compounds, which are composed of an iron core and a sugar polymer shell.

A small percentage of iron from the iron compound is released to the plasma, and may be associated with increased oxidative stress and protein oxidation. The study's hypothesis is that HD with large pore dialyzers may remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.

Ligand-bound iron removal is also hypothesized to be affected by dialysate calcium and bicarbonate concentrations, which may affect iron-ligand binding.

Study Specific aims are:

To evaluate

  1. Iron removal assessing dialysate iron levels.
  2. Effect of iron removal and it's associated experimental conditions on patient status, assessing plasma AOPP levels and inflammation related parameters

Study include 3 parts

  1. Comparing large to small pore dialyzers

    (To achieve baseline uniform conditions, patients will be on uniform dialysate bicarbonate and calcium concentrations of 33 mEq/L and 3 mEq/L,respectively, using large pore dialyzers during this part, besides the 2 HD sessions evaluating low pore dialyzers)

    and after few week break

    Using large pore dialyzers to compare

  2. Low to high dialysate bicarbonate concentration (using uniform dialysate calcium concentrations of 3 mEq/L)

    and after few week break

  3. Low to high dialysate calcium concentrations concentration (using uniform dialysate bicarbonate of 33 mEq/L)

In each part, patients will be first evaluated in HD without IV iron administration, which will serve as a control for evaluation after a week in HD with IV iron administration.

In each part, patients will be randomized to start either with one of the 2 experimental conditions, and after 1 week without evaluation will cross-over to the other experimental condition.

Patients may participate in 1,2 or the 3 parts of study depending on their will and condition.

  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 3 weeks prior to the study
  • Refusal to comply with limitations in fat containing food during HD with plasma sampling for AOPP evaluation
  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: NCT00638300

Locations
Israel
HD unit in Department of Nephrology in Soroka Universty Medical Center
Beer-sheva, Israel, 84101
HD unit in Bnai-zion Medical Center
Haifa, Israel
Rivka Ziv Medical center
Zefat, Israel
Sponsors and Collaborators
Soroka University Medical Center
Bnai Zion Medical Center
Rivka Ziv Medical Center
Investigators
Principal Investigator: David Tovbin, MD Soroka University Medical Center
  More Information

No publications provided

Responsible Party: David Tovbin MD, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00638300     History of Changes
Other Study ID Numbers: sor421306ctil
Study First Received: March 12, 2008
Last Updated: July 11, 2010
Health Authority: Israel: Institutional Review Board

Keywords provided by Soroka University Medical Center:
hemodialysis
iron
inflammation
atomic absorption
dialysate
advanced oxidation protein products
large pore dialysate
bicarbonate
calcium
citrate
ligand

Additional relevant MeSH terms:
Calcium, Dietary
Dialysis Solutions
Bone Density Conservation Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014