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

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charles Drew University of Medicine and Science
• Collaborators: National Institutes of Health (NIH); Rockwell Medical Technologies, Inc.
• Treatments: Dialysis Solutions; Iron

Criteria

Inclusion Criteria:Subjects with end stage renal disease undergoing maintenance hemodialysis three times a week.

• Subjects who have required IV iron at any time in the 2 months preceding enrollment.

Exclusion Criteria:

• Subjects with absolute iron deficiency at the time of enrollment In hemodialysis subjects "absolute iron deficiency"

• Subjects with a current malignancy involving sites other than skin.

• Subjects with a history of drug or alcohol abuse within the last 6 months