Iron Deficiency Anemia
Conditions
Keywords
Intravenous iron, ferumoxytol, iron deficiency anemia, Treatment of iron deficiency, Intolerance of or ineffectiveness of oral iron
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.
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.
Interventions
DRUGferumoxytol
IV administration of 1020 mg of ferumoxytol in 15 minutes
Sponsors
AMAG Pharmaceuticals, Inc.
Auerbach Hematology Oncology Associates P C
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Total Dose 1020 mg Feramoxytol All participants receive 1020 mg of Feramoxytol. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Total Dose 1020 mg Feramoxytol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age, Continuous | 53.4 years FULL_RANGE 67 |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.
Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Dose 1020 mg 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 |
| Total Dose 1020 mg Feramoxytol | 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 |
| Total Dose 1020 mg 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 8 | 92 percentage of participants |
| Total Dose 1020 mg Feramoxytol | 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
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Dose 1020 mg 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 |