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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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End Stage Renal Disease (ESRD)

Intervention / Treatment
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* Drug: soluble ferric pyrophosphate (SFP)
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SFP dialysate<br>dialysate with added soluble ferric pyrophosphate (SFP) | Drug: soluble ferric pyrophosphate (SFP)<br>* 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)<br>|
| Placebo Comparator: standard dialysate<br>standard dialysate without soluble ferric pyrophosphate (SFP) | Other: placebo<br>* Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis