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Iron Indices and Intravenous Ferumoxytol: Time to Steady State

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01148745
First Posted: June 22, 2010
Last Update Posted: March 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dialysis Clinic, Inc.
  Purpose
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.

Condition Intervention Phase
Iron Deficiency Anemia Drug: ferumoxytol Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Iron Indices and Intravenous Ferumoxytol: Time to Steady State

Resource links provided by NLM:


Further study details as provided by Dialysis Clinic, Inc.:

Primary Outcome Measures:
  • Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize [ Time Frame: pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration ]
    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.


Secondary Outcome Measures:
  • Transferrin Saturation (TSAT) [ Time Frame: 7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days. ]
    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

  • Serum Ferritin [ Time Frame: 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14) ]
    Serum ferritin values were measured at all visits


Enrollment: 15
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Feraheme

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148745


Locations
United States, New Jersey
Dialysis Clinic, Inc.
North Brunswick, New Jersey, United States, 08902
Sponsors and Collaborators
Dialysis Clinic, Inc.
Investigators
Principal Investigator: Toros Kapoian, MD DCI North Brunswick
  More Information

Responsible Party: Dialysis Clinic, Inc.
ClinicalTrials.gov Identifier: NCT01148745     History of Changes
Other Study ID Numbers: DCI-0001
First Submitted: June 21, 2010
First Posted: June 22, 2010
Results First Submitted: July 19, 2011
Results First Posted: March 30, 2012
Last Update Posted: March 30, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions