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

End Stage Renal Disease (ESRD) Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00604565
Study type Interventional
Source Charles Drew University of Medicine and Science
Contact
Status Terminated
Phase N/A
Start date January 2008
Completion date December 2010
View Details
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