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

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ClinicalTrials.gov Identifier: NCT00604565
Recruitment Status : Terminated (major planned changes to study design)
First Posted : January 30, 2008
Results First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Rockwell Medical Technologies, Inc.
Information provided by (Responsible Party):
Ajay Gupta, Charles Drew University of Medicine and Science

January 17, 2008
January 30, 2008
March 11, 2015
August 31, 2015
August 31, 2015
January 2008
December 2010   (Final data collection date for primary outcome measure)
  • TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS [ Time Frame: 36 weeks ]
    Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of subjects affected are listed only. The details of the types of events that took place are reported in the Adverse Events section.
  • TOTAL NUMBER OF ADVERSE EVENTS [ Time Frame: 36 weeks ]
    Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of events are listed only. The details of the types of events that took place are reported in the Adverse Events section.
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 ]
Complete list of historical versions of study NCT00604565 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
End Stage Renal Disease (ESRD)
  • Drug: soluble ferric pyrophosphate (SFP)

    Subjects will be randomized to undergo dialysis with either Fe-HD (dialysate containing 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)

  • Other: placebo
    Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
  • Experimental: SFP dialysate
    dialysate with added soluble ferric pyrophosphate (SFP)
    Intervention: Drug: soluble ferric pyrophosphate (SFP)
  • Placebo Comparator: standard dialysate
    standard dialysate without soluble ferric pyrophosphate (SFP)
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
30
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00604565
SFP-NIH-01
NIH-FP-01
No
Not Provided
Not Provided
Ajay Gupta, Charles Drew University of Medicine and Science
Charles Drew University of Medicine and Science
  • National Institutes of Health (NIH)
  • Rockwell Medical Technologies, Inc.
Principal Investigator: Ajay Gupta, MD Rockwell Medical Technologies, Inc.
Charles Drew University of Medicine and Science
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP