Iron Indices and Intravenous Ferumoxytol: Time to Steady State

The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as well as to determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA) hemodialysis patients.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Drug: ferumoxytol

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • North Brunswick, New Jersey, United States, 08902
      • Dialysis Clinic, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic hemodialysis subjects who have received dialysis treatment for more than 90 days
• TSAT less than or equal to 25 percent
• Serum ferritin less than or equal to 200 nanograms/milliliter (ng/mL)
• (Female) Subjects are willing to use reliable contraception, or have undergone menopause (chemical or surgical)
• Subjects who are able to read and write in English
• Subjects who have signed consent

Exclusion Criteria:

• Subjects who have been enrolled in a clinical trial within the past 30 days
• Subjects who have received IV iron within 4 weeks of the start of the study
• Serum ferritin greater than or equal to 1200 ng/dL
• Hemoglobin (Hb) less than 10 grams/deciliter (g/dL), or greater than 13.5 g/dL
• Evidence of iron overload
• Known hypersensitivity to ferumoxytol or any of its components
• Anemia caused by conditions other than iron deficiency
• Subjects with elective surgeries scheduled within the next 3 months
• Subjects with elective magnetic resonance procedure scheduled during the study period
• Subjects who have been hospitalized within the past 30 days (excluding vascular access care)
• Subjects who have received a blood transfusion in the past 30 days
• Subjects who are transfusion dependent
• (Female) Subjects who are pregnant or nursing
• Subjects with known inflammatory conditions which may affect serum ferritin
• Subjects who are considered to be clinically unstable at the discretion of Principal Investigator (P.I.)
• Subjects who have a clinically unstable blood pressure (BP) of systolic greater than 180 millimeters of mercury (mmHg) and/or diastolic greater than 100 mmHg (sitting, pre-dialysis)
• Subjects with life expectancy less than 6 months
• Subjects who refuse to sign consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ferumoxytol; FDA approved drug	Drug: ferumoxytol; 510 milligram (mg) intravenous (IV) injection (30 mg/second (sec) over 17 seconds) after at least one hour of hemodialysis (HD), second 510 mg IV injection administered at next consecutive dialysis treatment (3-5 days after first injection); Other Names: Feraheme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize	TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values <0.05 were considered statistically significant.	pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transferrin Saturation (TSAT)	Transferrin saturation (TSAT) measured as a percentage, is a medical laborastory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100	7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.
Serum Ferritin	Serum ferritin values were measured at all visits	7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)

Collaborators and Investigators

• Sponsor: Dialysis Clinic, Inc.
• Investigators: Principal Investigator: Toros Kapoian, MD, DCI North Brunswick

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: June 21, 2010
• First Submitted That Met QC Criteria: June 21, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Estimate): March 30, 2012
• Last Update Submitted That Met QC Criteria: March 28, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Hematinics; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Ferrosoferric Oxide
• Other Study ID Numbers: DCI-0001