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

This study has been terminated.
(major planned changes to study design)
Sponsor:
Collaborators:
Rockwell Medical Technologies, Inc.
Information provided by (Responsible Party):
Ajay Gupta, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00604565
First received: January 17, 2008
Last updated: August 5, 2015
Last verified: August 2015
  Purpose

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 Intervention
End Stage Renal Disease (ESRD)
Drug: soluble ferric pyrophosphate (SFP)
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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 End Stage Renal Disease (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:
  • TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 11
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  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
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
Rockwell Medical Technologies, Inc.
Investigators
Principal Investigator: Ajay Gupta, MD Rockwell Medical Technologies, Inc.
  More Information

No publications provided

Responsible Party: Ajay Gupta, Ajay Gupta, MD, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00604565     History of Changes
Other Study ID Numbers: SFP-NIH-01, NIH-FP-01
Study First Received: January 17, 2008
Results First Received: March 11, 2015
Last Updated: August 5, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Dialysis Solutions
Iron
Growth Substances
Micronutrients
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on September 03, 2015