Iron Indices and Intravenous Ferumoxytol: Time to Steady State

Iron Deficiency Anemia Clinical Trial

Official title:

Iron Indices and Intravenous Ferumoxytol: Time to Steady State

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148745
• Other study ID #: DCI-0001
• Status: Completed
• Phase: Phase 4
• First received: June 21, 2010
• Last updated: March 28, 2012
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: March 2012
• Source: Dialysis Clinic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

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)

Locations

Country	Name	City	State
United States	Dialysis Clinic, Inc.	North Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Dialysis Clinic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	Serum Ferritin	Serum ferritin values were measured at all visits	7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)	No