Iron Indices and Intravenous Ferumoxytol: Time to Steady State

NCT01148745 | Completed Phase 4 Results

• 1 other identifier: DCI-0001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Transferrin Saturation (TSAT)

  7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.

• Serum Ferritin

  7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)

Study Arms (1)

ferumoxytol

OTHER

FDA approved drug

Drug: ferumoxytol

Interventions

ferumoxytol DRUG

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)

Also known as: Feraheme

ferumoxytol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Dialysis Clinic, Inc.: lead

Study Sites (1)

Dialysis Clinic, Inc.

North Brunswick, New Jersey, 08902, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Results Point of Contact

• Title: Dr. Toros Kapoian, M.D., F.A.C.P.
• Organization: Dialysis Clinic, Inc.

Toros.Kapoian@dciinc.org

732-940-8368

Study Officials

• Toros Kapoian, MD

  DCI North Brunswick

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 22, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 30, 2012
• Results First Posted: March 30, 2012

Record last verified: 2012-03

Locations

US (1)