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

Not Applicable

Terminated

• Conditions: End Stage Renal Disease (ESRD)
• Interventions: Other: placebo; Drug: soluble ferric pyrophosphate (SFP)

• Registration Number: NCT00604565
• Lead Sponsor: Charles Drew University of Medicine and Science

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-17
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-01-30
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2015-03-11
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-05
• Last Update Submitted: 2015-08-05
• Results First Posted: 2015-08-31
• Last Update Posted: 2015-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard dialysate	placebo	standard dialysate without soluble ferric pyrophosphate (SFP)
SFP dialysate	soluble ferric pyrophosphate (SFP)	dialysate with added soluble ferric pyrophosphate (SFP)

Primary Outcome Measures

Name	Time	Method
TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS	36 weeks	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	36 weeks	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.

Trial Locations

Locations (2)

RAI; 🇺🇸 Los Angeles, California, United States

University of Louisville Kidney Disease Program; 🇺🇸 Louisville, Kentucky, United States