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

Primary Purpose

End Stage Renal Disease (ESRD)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
soluble ferric pyrophosphate (SFP)
placebo
Sponsored by
Charles Drew University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End Stage Renal Disease (ESRD) focused on measuring Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RAI
  • University of Louisville Kidney Disease Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SFP dialysate

standard dialysate

Arm Description

dialysate with added soluble ferric pyrophosphate (SFP)

standard dialysate without soluble ferric pyrophosphate (SFP)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2008
Last Updated
August 5, 2015
Sponsor
Charles Drew University of Medicine and Science
Collaborators
National Institutes of Health (NIH), Rockwell Medical Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00604565
Brief Title
Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
major planned changes to study design
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles Drew University of Medicine and Science
Collaborators
National Institutes of Health (NIH), Rockwell Medical Technologies, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD)
Keywords
Hemodialysis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SFP dialysate
Arm Type
Experimental
Arm Description
dialysate with added soluble ferric pyrophosphate (SFP)
Arm Title
standard dialysate
Arm Type
Placebo Comparator
Arm Description
standard dialysate without soluble ferric pyrophosphate (SFP)
Intervention Type
Drug
Intervention Name(s)
soluble ferric pyrophosphate (SFP)
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
Primary Outcome Measure Information:
Title
TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS
Description
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.
Time Frame
36 weeks
Title
TOTAL NUMBER OF ADVERSE EVENTS
Description
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.
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Gupta, MD
Organizational Affiliation
Rockwell Medical Technologies, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
RAI
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
University of Louisville Kidney Disease Program
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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