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

NCT00604565 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2015-08-31

Study results available
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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.

Conditions

  • End Stage Renal Disease (ESRD)

Interventions

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)

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Rockwell Medical Technologies, Inc.

    collaborator INDUSTRY

  • Charles Drew University of Medicine and Science

    lead OTHER

Principal Investigators

  • Ajay Gupta, MD · Rockwell Medical Technologies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00604565 on ClinicalTrials.gov