Conditions: End Stage Renal Disease (ESRD)
Keywords: Hemodialysis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 11
Healthy volunteers: no

Brief summary:
In maintenance hemodialysis patients, regular administration of parenteral iron by addition of soluble ferric pyrophosphate (SFP) to the dialysate, when compared to conventional dialysate, is effective in preventing the development of iron deficiency, thereby maintaining hemoglobin level; is clinically safe and does not lead to oxidative stress or inflammation.

Detailed description:

Arms:
arm 1: dialysate with added soluble ferric pyrophosphate (SFP) arm 2: standard dialysate without soluble ferric pyrophosphate (SFP)

Interventions: intervention 1: soluble ferric pyrophosphate (SFP) intervention 2: placebo
Intervention descriptions: intervention 1: Subjects will be randomized to undergo dialysis with either Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL).

Control concentrate lacking SFP (C-HD) does not contain SFP (total iron = 0) intervention 2: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)

Protocol document: