NCT00604565

Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients

A Prospective, Randomized, Open-label, Multi-center, Controlled Clinical Trial of the Safety and Efficacy of Physiological Iron Maintenance in End Stage Renal Disease (ESRD) Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Charles Drew University of Medicine and Science · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease (ESRD)

Interventions

Type	Name	Description
DRUG	soluble ferric pyrophosphate (SFP)	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)
OTHER	placebo	Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-01-30
• Last updated: 2015-08-31
• Results posted: 2015-08-31

Locations

2 sites across 1 country: United States