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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
RAI
Los Angeles, California, United States
University of Louisville Kidney Disease Program
Louisville, Kentucky, United States
Start Date
January 1, 2008
Primary Completion Date
December 1, 2010
Completion Date
December 1, 2010
Last Updated
August 31, 2015
11
ACTUAL participants
soluble ferric pyrophosphate (SFP)
DRUG
placebo
OTHER
Lead Sponsor
Charles Drew University of Medicine and Science
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07165015