Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

North Brunswick, New Jersey 08902


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.


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


Study is Available At:


Original ID:

DCI-0001


NCT ID:

NCT01148745


Secondary ID:


Study Acronym:


Brief Title:

Iron Indices and Intravenous Ferumoxytol: Time to Steady State


Official Title:

Iron Indices and Intravenous Ferumoxytol: Time to Steady State


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dialysis Clinic, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Actual


Overall Contact Information

Official Name:Toros Kapoian, MD
Principal Investigator
DCI North Brunswick

Study Dates

Start Date:March 2010
Completion Date:May 2010
Completion Type:Actual
Primary Completion Date:April 2010
Primary Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 28, 2012
First Received Date:June 21, 2010
First Results Date:July 19, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Serum Ferritin
Time Frame:7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)
Safety Issues:False
Description:Serum ferritin values were measured at all visits
Outcome Type:Secondary Outcome
Measure:Transferrin Saturation (TSAT)
Time Frame:7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.
Safety Issues:False
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
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
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

Study Interventions

Intervention Type:Drug
Name:ferumoxytol
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)
Arm Name:ferumoxytol
Other Name:Feraheme

Study Arms

Study Arm Type:Other
Arm Name:ferumoxytol
Description:FDA approved drug

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Dialysis Clinic, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.