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

Charles Drew University of Medicine and Science11 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

End Stage Renal Disease (ESRD)

Interventions

soluble ferric pyrophosphate (SFP)DRUG

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)

placeboOTHER

Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

RAI

Los Angeles, California, United States

University of Louisville Kidney Disease Program

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 36 weeks

Data from ClinicalTrials.gov

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