Trial Outcomes & Findings for Total Dose Infusion of Ferumoxytol(1020mg) in 15 Minutes for Iron Deficiency Anemia (NCT NCT01374919)

NCT ID: NCT01374919

Last Updated: 2025-10-15

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: baseline 4 weeks and 8 weeks
• Results posted on: 2025-10-15

Participant Flow

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.

Participant milestones

Measure	Total Dose 1020 mg Feramoxytol All participants receive 1020 mg of Feramoxytol.
Overall Study STARTED	60
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Total Dose 1020 mg Feramoxytol All participants receive 1020 mg of Feramoxytol.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Total Dose 1020 mg Feramoxytol n=60 Participants All participants receive 1020 mg of Feramoxytol.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	53.4 years FULL_RANGE 67 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline 4 weeks and 8 weeks

Population: 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.

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

Outcome measures

Measure	Total Dose 1020 mg Feramoxytol n=58 Participants All participants receive 1020 mg of Feramoxytol.
Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit. Greater than 1 g/dl increase at week 4	85 percentage of participants
Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit. Greater than 2 g/dl at week 4	58 percentage of participants
Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit. Greater than 1 g/dl increase at week 8	92 percentage of participants
Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit. Greater than 2 g/dl increase at week 8	86 percentage of participants

SECONDARY outcome

Timeframe: immediate, 24 and 48 hours, one week and followup visit at 4 weeks

Outcome measures

Measure	Total Dose 1020 mg Feramoxytol n=60 Participants All participants receive 1020 mg of Feramoxytol.
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.	0 participants

Adverse Events

Total Dose 1020 mg Feramoxytol

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Total Dose 1020 mg Feramoxytol n=60 participants at risk All participants receive 1020 mg of Feramoxytol.
Musculoskeletal and connective tissue disorders Arthralgia/Myalgia/Muscle Spasm	23.3% 14/60 • 8 weeks from treatment day 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.
Musculoskeletal and connective tissue disorders Headache	13.3% 8/60 • 8 weeks from treatment day 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.
Musculoskeletal and connective tissue disorders Chest Pressure	6.7% 4/60 • 8 weeks from treatment day 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.
Skin and subcutaneous tissue disorders Pruritis	5.0% 3/60 • 8 weeks from treatment day 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.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 3/60 • 8 weeks from treatment day 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.
General disorders Flushing	5.0% 3/60 • 8 weeks from treatment day 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.
Gastrointestinal disorders abdominal pain	3.3% 2/60 • 8 weeks from treatment day 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.
General disorders Fever	1.7% 1/60 • 8 weeks from treatment day 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.
Gastrointestinal disorders dry mouth	1.7% 1/60 • 8 weeks from treatment day 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.
Respiratory, thoracic and mediastinal disorders dyspnea	1.7% 1/60 • 8 weeks from treatment day 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.
General disorders edema	1.7% 1/60 • 8 weeks from treatment day 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.
General disorders metallic taste	1.7% 1/60 • 8 weeks from treatment day 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.
Immune system disorders lip swelling	1.7% 1/60 • 8 weeks from treatment day 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.
Gastrointestinal disorders nausea	5.0% 3/60 • 8 weeks from treatment day 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.
General disorders dizziness	5.0% 3/60 • 8 weeks from treatment day 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.

Additional Information

Dr. Michael Auerbach

Auerbach Hematology Oncology Assoc

Phone: 410-780-4050

Email: mauerbachmd@abhemonc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place