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

End Stage Renal Disease (ESRD) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00604565
• Other study ID #: SFP-NIH-01
• Secondary ID: NIH-FP-01
• Status: Terminated
• Phase: N/A
• First received: January 17, 2008
• Last updated: August 5, 2015
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2015
• Source: Charles Drew University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• End Stage Renal Disease (ESRD)
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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)

Locations

Country	Name	City	State
United States	RAI	Los Angeles	California
United States	University of Louisville Kidney Disease Program	Louisville	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Charles Drew University of Medicine and Science	National Institutes of Health (NIH), Rockwell Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS	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.	36 weeks	Yes
Primary	TOTAL NUMBER OF ADVERSE EVENTS	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.	36 weeks	Yes