NCT00638300

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
OTHER	Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L	Effect of dialysate calcium concentration

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-12-01
• Completion: 2010-07-01
• First posted: 2008-03-19
• Last updated: 2010-07-13

Locations

3 sites across 1 country: Israel