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

Hemodialysis Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638300
• Other study ID #: sor421306ctil
• Status: Completed
• Phase: N/A
• First received: March 12, 2008
• Last updated: July 11, 2010
• Start date: March 2008
• Est. completion date: July 2010

Study information

• Verified date: March 2008
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Device:
• large pore (FX80) compared to small pore dialyzer (F8HPS)
Effect of pore size

Other:
• Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L
Effect of dialysate bicarbonate concentration
• Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L
Effect of dialysate calcium concentration

Locations

Country	Name	City	State
Israel	HD unit in Department of Nephrology in Soroka Universty Medical Center	Beer-sheva
Israel	HD unit in Bnai-zion Medical Center	Haifa
Israel	Rivka Ziv Medical center	Zefat

Sponsors (3)

Lead Sponsor	Collaborator
Soroka University Medical Center	Bnai Zion Medical Center, Rivka Ziv Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No