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Completed

NCT Number: NCT01148745

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dialysis Clinic, Inc.

North Brunswick, New Jersey, 08902, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Feraheme

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Dialysis Clinic, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2010
Registry last updated
Mar 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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