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.

Study Overview

• Status: Terminated
• Conditions: End Stage Renal Disease (ESRD)
• Intervention / Treatment: Drug: soluble ferric pyrophosphate (SFP); Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90059
      • RAI
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Kidney Disease Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Charles Drew University of Medicine and Science
• Collaborators: National Institutes of Health (NIH); Rockwell Medical Technologies, Inc.
• Investigators: Principal Investigator: Ajay Gupta, MD, Rockwell Medical Technologies, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 17, 2008
• First Submitted That Met QC Criteria: January 29, 2008
• First Posted (Estimate): January 30, 2008

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Hemodialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: SFP-NIH-01; NIH-FP-01