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

Removal of Ligand-bound Iron During Intravenous Iron Administration in Hemodialysis by Large Pore Dialyzers

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Patients
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Beer-sheva, Israel, 84101
    • HD unit in Department of Nephrology in Soroka Universty Medical Center
  • Haifa, Israel
    • HD unit in Bnai-zion Medical Center
  • Zefat, Israel
    • Rivka Ziv Medical center

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1. Dialysate Iron levels 2. Plasma levels of advanced oxidation protein products(AOPP)	Before HD, after 1 hour of HD with or without IV iron and at end of HD

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Collaborators: Bnai Zion Medical Center; Rivka Ziv Medical Center
• Investigators: Principal Investigator: David Tovbin, MD, Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: March 12, 2008
• First Submitted That Met QC Criteria: March 18, 2008
• First Posted (Estimate): March 19, 2008

Study Record Updates

• Last Update Posted (Estimate): July 13, 2010
• Last Update Submitted That Met QC Criteria: July 11, 2010
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: inflammation; hemodialysis; citrate; iron; calcium; bicarbonate; dialysate; ligand; atomic absorption; advanced oxidation protein products; large pore dialysate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Pharmaceutical Solutions; Calcium; Dialysis Solutions
• Other Study ID Numbers: sor421306ctil