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

This study has been terminated.
(Due to PI's non-compliance with IRB requirements)
Sponsor:
Collaborators:
Rockwell Medical Technologies, Inc.
Information provided by:
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00604565
First received: January 17, 2008
Last updated: August 28, 2009
Last verified: August 2009
  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)

Study Type: Interventional
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

Resource links provided by NLM:


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
Study Completion Date: August 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Detailed Description:

This study has been terminated.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
DaVita
Los Angeles, California, United States, 90033
RAI
Los Angeles, California, United States, 90059
Sponsors and Collaborators
Charles Drew University of Medicine and Science
Rockwell Medical Technologies, Inc.
Investigators
Principal Investigator: Ajay Gupta, MD Charles Drew University
  More Information

No publications provided

Responsible Party: Ajay Gupta, MD, PI, Charles Drew University (CDU)
ClinicalTrials.gov Identifier: NCT00604565     History of Changes
Other Study ID Numbers: SFP-NIH-01, NIH-FP-01
Study First Received: January 17, 2008
Last Updated: August 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Charles Drew University of Medicine and Science:
Hemodialysis

Additional relevant MeSH terms:
Iron
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 30, 2014