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Iron Indices and Intravenous Ferumoxytol: Time to Steady State

NCT ID: NCT01148745

Last Updated: 2012-03-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Deficiency Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ferumoxytol

FDA approved drug

Group Type OTHER

ferumoxytol

Intervention Type 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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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Feraheme

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dialysis Clinic, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toros Kapoian, MD

Role: PRINCIPAL_INVESTIGATOR

DCI North Brunswick

Locations

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Dialysis Clinic, Inc.

North Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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DCI-0001

Identifier Type: -

Identifier Source: org_study_id