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

NCT00604565 | Terminated Results

• 2 other identifiers: SFP-NIH-01NIH-FP-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease (ESRD)

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

SFP dialysate

EXPERIMENTAL

dialysate with added soluble ferric pyrophosphate (SFP)

Drug: soluble ferric pyrophosphate (SFP)

standard dialysate

PLACEBO COMPARATOR

standard dialysate without soluble ferric pyrophosphate (SFP)

Other: placebo

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)

SFP dialysate

placebo OTHER

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

standard dialysate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have required IV iron at any time in the 2 months preceding enrollment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• National Institutes of Health (NIH): collaborator
• Rockwell Medical Technologies, Inc.: collaborator

Study Sites (2)

RAI

Los Angeles, California, 90059, United States

Location

University of Louisville Kidney Disease Program

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study suspended after 1st 11 subjects enrolled. Study design changed significantly upon re-initiation, so 1st 11 subjects analyzed for safety only; no efficacy. Efficacy analysis from study after re-initiation is found under protocol NIH-FP-01 PRIME.

Results Point of Contact

• Title: Ajay Gupta, MD
• Organization: Rockwell Medical

rd@rockwellmed.com

248-960-9009

Study Officials

• Ajay Gupta, MD

  Rockwell Medical Technologies, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ajay Gupta, MD

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 30, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 31, 2015
• Results First Posted: August 31, 2015

Record last verified: 2015-08

Locations

US (2)