Iron Indices and Intravenous Ferumoxytol: Time to Steady State

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dialysis Clinic, Inc.
ClinicalTrials.gov Identifier:
NCT01148745
First received: June 21, 2010
Last updated: March 28, 2012
Last verified: March 2012
  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: 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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dialysis Clinic, Inc.
ClinicalTrials.gov Identifier: NCT01148745     History of Changes
Other Study ID Numbers: DCI-0001
Study First Received: June 21, 2010
Results First Received: July 19, 2011
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014