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Iron Indices and Intravenous Ferumoxytol: Time to Steady State

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ferumoxytol
Sponsored by
Dialysis Clinic, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iron Deficiency Anemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dialysis Clinic, Inc.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ferumoxytol

Arm Description

FDA approved drug

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Serum Ferritin
Serum ferritin values were measured at all visits

Full Information

First Posted
June 21, 2010
Last Updated
March 28, 2012
Sponsor
Dialysis Clinic, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01148745
Brief Title
Iron Indices and Intravenous Ferumoxytol: Time to Steady State
Official Title
Iron Indices and Intravenous Ferumoxytol: Time to Steady State
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dialysis Clinic, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ferumoxytol
Arm Type
Other
Arm Description
FDA approved drug
Intervention Type
Drug
Intervention Name(s)
ferumoxytol
Other Intervention Name(s)
Feraheme
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize
Description
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.
Time Frame
pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration
Secondary Outcome Measure Information:
Title
Transferrin Saturation (TSAT)
Description
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
Time Frame
7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.
Title
Serum Ferritin
Description
Serum ferritin values were measured at all visits
Time Frame
7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toros Kapoian, MD
Organizational Affiliation
DCI North Brunswick
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dialysis Clinic, Inc.
City
North Brunswick
State/Province
New Jersey
ZIP/Postal Code
08902
Country
United States

12. IPD Sharing Statement

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Iron Indices and Intravenous Ferumoxytol: Time to Steady State

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