Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients
In maintenance hemodialysis patients, regular administration of parenteral iron by addition of 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||A Prospective, Randomized, Open-label, Multi-center, Controlled Clinical Trial of the Safety and Efficacy of Physiological Iron Maintenance in ESRD Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate|
- sparing the need for supplemental intravenous iron required to maintain hemoglobin levels. Hemoglobin, Hematology, TSAT,Fe Panel,Chemistry Profile will be obtained [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
- compare subjects receiving SFP dialysate versus conventional dialysate with regard to:Hemoglobin,Markers of inflammation and oxidative stress, iron overload or deficiency [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
- To compare the two study groups (conventional dialysate versus SFP dialysate) Markers of inflammation and oxidative stress as described in the text. · Acute Oxidative stress/inflammation induced by the first dialysis session. [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||August 2009|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
Drug: soluble ferric pyrophosphate (SFP)
Subjects will be randomized to undergo dialysis with either Fe-HD (dialysate containing SFP) or C-HD (conventional dialysate lacking 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)
This study has been terminated.
|United States, California|
|Los Angeles, California, United States, 90059|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Ajay Gupta, MD||Charles Drew University|