Total Dose Infusion of Ferumoxytol(1020mg) in 15 Minutes for Iron Deficiency Anemia

• Sponsor: Auerbach Hematology Oncology Associates P C (Other)
• Overall Status: Completed
• CT.gov ID: NCT01374919
• Collaborator: AMAG Pharmaceuticals, Inc. (Industry)
• Enrollment: 60
• Location: 1
• Arm: 1
• Duration (Months): 9
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

The aim of the study is to recruit 30 patients who have been referred to Auerach Hematology Oncology Assoc. for the treatment of iron defeciency anemia with iv iron (Ferumoxytol 1020 mg) administered via infusion pump over 15 minutes.

To ascertain acute safety and tolerability of ferumoxytol during immediate post dosing observation period.

Assess additional safety profile and laboratory assessment at follow up visit and interim telephone follow up.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia	Drug: ferumoxytol	N/A

Detailed Description

Ferumoxytol, a modified iron dextran, which allows the rapid administration of IV iron without free iron release, was approved for a 510 mg injection to be administered in not less than 17 seconds. Although this represents a felicitous treatment for patients who come frequently, such as dialysis and chemotherapy patients, multiple publications suggest that full dose replacement is usually at the 1000 mg level. No studies extant are available with this dosing schedule for ferumoxytol. In this trial, iron deficient patients with hemoglobin levels of <11.0 grams per deciliter will be consented to received 1020 mg (two 510 mg vials) of ferumoxytol in 15 minutes. Vital signs will be performed at 5, 10, 15, 30 and 60 minutes. Followup phone calls for any clinical adverse events will be made at 24-48 hours and one week after administration. At four weeks follow-up hematologic and serologic (iron parameters) will be made along with a physician visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Total Dose Infusion of Ferumoxytol (1020mg) in 15 Minutes for Iron Defeciency Anemia
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: ferumoxytol IV administration of 1020 mg of ferumoxytol in 15 minutes	Drug: ferumoxytol; IV administration of 1020 mg of ferumoxytol in 15 minutes; Other Names: Feraheme, intravenous iron, total dose infusion

Outcome Measures

Primary Outcome Measures

1. Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit. [baseline 4 weeks and 8 weeks]

   Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8

Secondary Outcome Measures

1. Number of Participants With Treatment Related Serious Adverse Events. Calls for Minor Side Effects Will Occur at 24 and 48 Hours and One Week. A Followup Visit Will Occur at 4 Weeks. [immediate, 24 and 48 hours, one week and followup visit at 4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Iron deficiency anemia intolerant of or failure to respond to oral iron or condition where oral iron is known to be ineffective or harmful.

• Subject must be able to be contacted at 24-48 hours after dose and come for followup at four weeks.

• Subject must be capable of understanding informed consent

• No other form of iron may be taken within four weeks of consent or for four weeks after treatment

Exclusion Criteria:

• History of hypersensitivity to ferumoxytol.

• Imminent dialysis.

• Anemia due to other etiology.

• Parenteral iron within 4 weeks of consent.

• Pregnancy.

• Erythropoiesis stimulating agent within 30 days of consent.

• Other illness that would interfere with participation or understanding of trial.

• Major surgery planned within four weeks of consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Auerbach Hematology and Oncology	Baltimore	Maryland	United States	21237

Sponsors and Collaborators

• Auerbach Hematology Oncology Associates P C
• AMAG Pharmaceuticals, Inc.

Investigators

• Principal Investigator: Michael Auerbach, MD, Auerbach Hematology and Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Auerbach MD, Principal Investigator, Auerbach Hematology Oncology Associates P C
• ClinicalTrials.gov Identifier: NCT01374919
• Other Study ID Numbers: Ferumoxytol 1020
• First Posted: Jun 16, 2011
• Last Update Posted: Mar 14, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Michael Auerbach MD, Principal Investigator, Auerbach Hematology Oncology Associates P C: Intravenous iron; ferumoxytol; iron deficiency anemia; Treatment of iron deficiency; Intolerance of or ineffectiveness of oral iron
• Additional relevant MeSH terms: Anemia; Anemia, Iron-Deficiency; Deficiency Diseases; Ferrosoferric Oxide

Study Results

Participant Flow

Recruitment Details	Patients were recruited from routine referrals from obgyns, gastroenterologists, bariatric surgeons, general internists and nephrologists. All patients were iron deficient and anemic. All were oral iron intolerant. The data were presented at the 2012 American Society of Hematology meeting.

Arm/Group Title	Total Dose 1020 mg Feramoxytol
Arm/Group Description	All participants receive 1020 mg of Feramoxytol.
Period Title: Overall Study
STARTED	60
COMPLETED	58
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Total Dose 1020 mg Feramoxytol
Arm/Group Description	All participants receive 1020 mg of Feramoxytol.
Overall Participants	60
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	42 70%
>=65 years	18 30%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	53.4 (67)
Sex: Female, Male (Count of Participants)
Female	48 80%
Male	12 20%
Region of Enrollment (participants) [Number]
United States	60 100%

Outcome Measures

1. Primary Outcome

Title	Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.
Description	Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8
Time Frame	baseline 4 weeks and 8 weeks

Outcome Measure Data

Analysis Population Description

Two patients had minor infusion reactions and refused rechallenge. All other patients completed the study. Their hemoglobin levels, the primary outcome, were obtained at 4 and 8 weeks.

Arm/Group Title	Total Dose 1020 mg Feramoxytol
Arm/Group Description	All participants receive 1020 mg of Feramoxytol.
Measure Participants	58
Greater than 1 g/dl increase at week 4	85 141.7%
Greater than 2 g/dl at week 4	58 96.7%
Greater than 1 g/dl increase at week 8	92 153.3%
Greater than 2 g/dl increase at week 8	86 143.3%

2. Secondary Outcome

Title	Number of Participants With Treatment Related Serious Adverse Events. Calls for Minor Side Effects Will Occur at 24 and 48 Hours and One Week. A Followup Visit Will Occur at 4 Weeks.
Time Frame	immediate, 24 and 48 hours, one week and followup visit at 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total Dose 1020 mg Feramoxytol
Arm/Group Description	All participants receive 1020 mg of Feramoxytol.
Measure Participants	60
Number [participants]	0 0%

Adverse Events

Time Frame	8 weeks from treatment day
Adverse Event Reporting Description	Patients were observed for one hour after administration. Telephone calls were made at 24 and 48 hours and 7 days for delayed AEs. Follow visits in the office occurred at 4 and 8 weeks.
Arm/Group Title	Total Dose 1020 mg Feramoxytol
Arm/Group Description	All participants receive 1020 mg of Feramoxytol.
All Cause Mortality
	Total Dose 1020 mg Feramoxytol
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Total Dose 1020 mg Feramoxytol
	Affected / at Risk (%)	# Events
Total	0/60 (0%)
Other (Not Including Serious) Adverse Events
	Total Dose 1020 mg Feramoxytol
	Affected / at Risk (%)	# Events
Total	22/60 (36.7%)
Gastrointestinal disorders
abdominal pain	2/60 (3.3%)
dry mouth	1/60 (1.7%)
nausea	3/60 (5%)
General disorders
Flushing	3/60 (5%)
Fever	1/60 (1.7%)
edema	1/60 (1.7%)
metallic taste	1/60 (1.7%)
dizziness	3/60 (5%)
Immune system disorders
lip swelling	1/60 (1.7%)
Musculoskeletal and connective tissue disorders
Arthralgia/Myalgia/Muscle Spasm	14/60 (23.3%)
Headache	8/60 (13.3%)
Chest Pressure	4/60 (6.7%)
Respiratory, thoracic and mediastinal disorders
Cough	3/60 (5%)
dyspnea	1/60 (1.7%)
Skin and subcutaneous tissue disorders
Pruritis	3/60 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.