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

Sponsors and Collaborators:	Charles Drew University of Medicine and Science National Institutes of Health (NIH)
Information provided by:	Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:	NCT00604565

Purpose

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.

Condition	Intervention
ESRD	Drug: soluble ferric pyrophosphate (SFP)

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Ferric pyrophosphate Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Charles Drew University of Medicine and Science:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	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)

Arms

Assigned Interventions

A: Active Comparator

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604565

Contacts

Contact: Sarah L Grimberg, BS

949-428-6625

sarah.grimberg@clindatrix.com

Locations

United States, California
RAI	Recruiting
Los Angeles, California, United States, 90059
Contact: Joel M Barra, BSBM 424-558-0603 joel.barra@gmail.com
Principal Investigator: Ajay Gupta, MD

Sponsors and Collaborators

Charles Drew University of Medicine and Science

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Ajay Gupta, MD

Charles Drew University

More Information

Responsible Party:	Charles Drew University (CDU) ( Ajay Gupta, MD, PI )
Study ID Numbers:	SFP-NIH-01, NIH-FP-01
Study First Received:	January 17, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00604565
Health Authority:	United States: Food and Drug Administration

Keywords provided by Charles Drew University of Medicine and Science:

Hemodialysis

Study placed in the following topic categories:

Benzocaine
Iron

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009