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

Charles Drew University of Medicine and Science

Status: Terminated

Conditions: End Stage Renal Disease (ESRD)

Treatments: Drug: soluble ferric pyrophosphate (SFP); Other: placebo

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00604565

NIH-FP-01

SFP-NIH-01

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

11 participants in 2 patient groups, including a placebo group

SFP dialysate

Experimental group

Description:

dialysate with added soluble ferric pyrophosphate (SFP)

Treatment:

Drug: soluble ferric pyrophosphate (SFP)

standard dialysate

Placebo Comparator group

Description:

standard dialysate without soluble ferric pyrophosphate (SFP)

Treatment:

Other: placebo