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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease (ESRD) Drug: soluble ferric pyrophosphate (SFP) Other: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 End Stage Renal Disease (ESRD) Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate
Study Start Date : January 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SFP dialysate
dialysate with added soluble ferric pyrophosphate (SFP)
 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)
Placebo Comparator: standard dialysate
standard dialysate without soluble ferric pyrophosphate (SFP)
 Other: placebo
Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604565


Locations
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United States, California
RAI
Los Angeles, California, United States, 90059
United States, Kentucky
University of Louisville Kidney Disease Program
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Charles Drew University of Medicine and Science
National Institutes of Health (NIH)
Rockwell Medical Technologies, Inc.
Investigators
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Principal Investigator: Ajay Gupta, MD Rockwell Medical Technologies, Inc.
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ajay Gupta, Ajay Gupta, MD, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00604565    
Other Study ID Numbers: SFP-NIH-01
NIH-FP-01
First Posted: January 30, 2008    Key Record Dates
Results First Posted: August 31, 2015
Last Update Posted: August 31, 2015
Last Verified: August 2015
Keywords provided by Ajay Gupta, Charles Drew University of Medicine and Science:
Hemodialysis
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency