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

NCT ID: NCT00638300

Last Updated: 2010-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2010-07-31

Brief 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.

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.

Conditions

Hemodialysis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

1

large pore dialyzers (FX80, Fresenius, Germany)

Group Type: EXPERIMENTAL

large pore (FX80) compared to small pore dialyzer (F8HPS)

Intervention Type: DEVICE

Effect of pore size

2

small pore dialyzers ( F8HPS, Fresenius, Germany)

Group Type: EXPERIMENTAL

large pore (FX80) compared to small pore dialyzer (F8HPS)

Intervention Type: DEVICE

Effect of pore size

A

dialysate bicarbonate concentration of 33 mEq/l

Group Type: EXPERIMENTAL

Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L

Intervention Type: OTHER

Effect of dialysate bicarbonate concentration

B

dialysate bicarbonate concentration of 40 mEq/l

Group Type: EXPERIMENTAL

Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L

Intervention Type: OTHER

Effect of dialysate bicarbonate concentration

I

dialysate calcium concentration of 3 mEq/L

Group Type: EXPERIMENTAL

Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L

Intervention Type: OTHER

Effect of dialysate calcium concentration

II

dialysate calcium concentration of 2.5 mEq/L

Group Type: EXPERIMENTAL

Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L

Intervention Type: OTHER

Effect of dialysate calcium concentration

Interventions

large pore (FX80) compared to small pore dialyzer (F8HPS)

Effect of pore size

Intervention Type: DEVICE

Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L

Effect of dialysate bicarbonate concentration

Intervention Type: OTHER

Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L

Effect of dialysate calcium concentration

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: collaborator

Rivka Ziv Medical Center

UNKNOWN

Sponsor Role: collaborator

Soroka University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Soroka University Medical Center

Principal Investigators

David Tovbin, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

HD unit in Department of Nephrology in Soroka Universty Medical Center

Beersheba, , Israel

HD unit in Bnai-zion Medical Center

Haifa, , Israel

Rivka Ziv Medical center

Safed, , Israel

Countries

Israel

Other Identifiers

sor421306ctil

Identifier Type: -

Identifier Source: org_study_id