Removal of Ligand-bound Iron During Intravenous (IV) Iron Administration in Hemodialysis (HD)
Condition: Hemodialysis Patients
Study type: Interventional

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.
    

Intervention name(s): large pore (FX80) compared to small pore dialyzer (F8HPS); Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L; Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L
Intervention type(s): Device; Other; Other
Intervention description(s): Effect of pore size; Effect of dialysate bicarbonate concentration; Effect of dialysate calcium concentration
Intervention MeSH terms: Dialysis Solutions; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: hemodialysis; iron; inflammation; atomic absorption; dialysate; advanced oxidation protein products; large pore dialysate; bicarbonate; calcium; citrate; ligand