Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2008 |
| End Date: | December 2010 |
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
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.
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.
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
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