A Trial of Ferumoxytol for the Episodic Treatment of Iron... | NCT01114217

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ferumoxytol	Experimental	Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139]. Participants enrolled in AMAG-FER-IDA-303, a 6-month Extension Study, were evaluated monthly and could receive treatment with ferumoxytol only if they met criteria defined as persistent or recurrent IDA, hemoglobin <11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) <20% at any evaluation visit, (except study termination visit). Participants who met criteria began a 5-week treatment period (TP) and received 2 doses of ferumoxytol 510 mg intravenously (IV). The first IV 510-mg dose was administered on TP Day 1 (Baseline); the second 2-8 (5±3) days after Dose 1. The first treatment course with ferumoxytol for participants who previously received placebo in AMAG-FER-IDA-301 was considered Course 1; Course 2 included participants who previously received ferumoxytol in AMAG-FER-IDA-301; subsequent treatment courses were serially numbered.	Drug: Ferumoxytol

Name	Type	Description	Arm Group Labels	Other Names
Ferumoxytol	Drug	IV Ferumoxytol	Ferumoxytol	Feraheme

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol	Mean change in hemoglobin from TP Baseline (Day 1) to TP Week 5 following the first dose of ferumoxytol was calculated as: Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing of Course 1. Change from Baseline used an imputed value of 0 for missing values at the post-baseline visit.	TP Baseline (Day 1), TP Week 5

Secondary Outcomes

Measure	Description	Time Frame
Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course	Mean change in hemoglobin from TP Baseline to TP Week 5 following each course of ferumoxytol after the first course was calculated for each participant as: Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trial Site		Birmingham	Alabama		United States
Clinical Trial Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26572233	Background	Vadhan-Raj S, Ford DC, Dahl NV, Bernard K, Li Z, Allen LF, Strauss WE. Safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy: Results of a phase III, open-label, 6-month extension study. Am J Hematol. 2016 Feb;91(2):E3-5. doi: 10.1002/ajh.24240. No abstract available.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Received Ferumoxytol in IDA-303	Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139]. Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent iron deficiency anemia (IDA), defined as hemoglobin <11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) <20% at any monthly evaluation visit (with the exception of the Study Termination visit), began a 5-week Treatment Period (TP) and received a total of 2 doses of ferumoxytol 510 milligrams (mg) intravenously (IV). The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 grams (g).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Received Ferumoxytol in IDA-303	Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139]. Participants in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.
BG001	Did Not Receive Ferumoxytol in IDA-303	Participants who received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139] and did not receive ferumoxytol during AMAG-FER-IDA-303.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0002.6± 1.55

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		t-test, 2 sided		<0.0001														Other

Secondary

Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course

Mean change in hemoglobin from TP Baseline to TP Week 5 following each course of ferumoxytol after the first course was calculated for each participant as:

Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.

ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.

Posted

Mean

Standard Deviation

g/dL

TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

ID	Title	Description
OG000	Ferumoxytol	Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.

Secondary

Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5

Proportion of participants with an increase in hemoglobin ≥2.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.

ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.

Participants with no post-baseline hemoglobin values were classified as not achieving the increase.

Percentages are based on the number of participants in each course.

Posted

Number

percentage of participants

TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

ID	Title	Description
OG000	Ferumoxytol	Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.

Secondary

Percentage Of Participants Who Achieved A Hemoglobin Level ≥12.0 g/dL At Any Time From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol

Proportion of participants who achieved a hemoglobin level ≥12.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.

ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.

Participants with no post-baseline hemoglobin values were classified as not achieving the increase.

Percentages are based on the number of participants in each course.

Posted

Number

percentage of participants

TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

ID	Title	Description
OG000	Ferumoxytol	Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.

Secondary

Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol

Mean change in TSAT from TP Baseline to TP Week 5 following each course of ferumoxytol.

ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for TSAT at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.

Posted

Mean

Standard Deviation

percentage of saturation

TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

ID	Title	Description
OG000	Ferumoxytol	Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.

Units	Counts
Participants	OG000

Secondary

Patient-reported Outcome Measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol

The FACIT-Fatigue questionnaire is a 13-item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue.

Mean change in FACIT-Fatigue questionnaire from TP Baseline to TP Week 5 following each course of ferumoxytol was calculated as:

FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline).

TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing in each course.

If the TP Week 5 FACIT-Fatigue Score value was missing, the change from TP Baseline was conservatively imputed as zero.

ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable FACIT-Fatigue Questionnaire data at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.

Posted

Mean

Standard Deviation

units on a scale

TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

ID	Title	Description
OG000	Ferumoxytol	Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.

Secondary

Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline

Days to event was defined as the days from Baseline to the first time the participant met the criteria. Participants without any post-Baseline study visits were not included in this analysis.

The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.

ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.

Posted

Mean

Inter-Quartile Range

days

TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3

ID	Title	Description
OG000	Ferumoxytol	Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Received Ferumoxytol	Participants received ferumoxytol during AMAG-FER-IDA-301 [NCT01114139]. Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.			22	337	93	337

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (13.0)	EG0002 events2 affected337 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA (13.0)	EG0002 events2 affected337 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (13.0)	EG0002 events2 affected337 at risk
Small intestinal stenosis	Gastrointestinal disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Chest pain	General disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Bacteraemia	Infections and infestations	MedDRA (13.0)	EG0001 events1 affected337 at risk
Bronchitis	Infections and infestations	MedDRA (13.0)	EG0002 events1 affected337 at risk
Cellulitis	Infections and infestations	MedDRA (13.0)	EG0001 events1 affected337 at risk
Laryngitis	Infections and infestations	MedDRA (13.0)	EG0002 events1 affected337 at risk
Osteomyelitis	Infections and infestations	MedDRA (13.0)	EG0001 events1 affected337 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (13.0)	EG0001 events1 affected337 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (13.0)	EG0001 events1 affected337 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (13.0)	EG0001 events1 affected337 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA (13.0)	EG0001 events1 affected337 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (13.0)	EG0001 events1 affected337 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	EG0001 events1 affected337 at risk
Colon cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	EG0001 events1 affected337 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	EG0001 events1 affected337 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (13.0)	EG0002 events2 affected337 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Vocal cord disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (13.0)	EG0001 events1 affected337 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (13.0)	EG0006 events5 affected337 at risk
Constipation	Gastrointestinal disorders	MedDRA (13.0)	EG0008 events7 affected337 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (13.0)	EG00010 events10 affected337 at risk
Nausea	Gastrointestinal disorders	MedDRA (13.0)	EG00020 events17 affected337 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	EG00012 events10 affected337 at risk
Fatigue	General disorders	MedDRA (13.0)	EG0009 events9 affected337 at risk
Oedema peripheral	General disorders	MedDRA (13.0)	EG0006 events6 affected337 at risk
Pyrexia	General disorders	MedDRA (13.0)	EG0005 events5 affected337 at risk
Nasopharyngitis	Infections and infestations	MedDRA (13.0)	EG00010 events10 affected337 at risk
Sinusitis	Infections and infestations	MedDRA (13.0)	EG0006 events5 affected337 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (13.0)	EG0006 events6 affected337 at risk
Urinary tract infection	Infections and infestations	MedDRA (13.0)	EG00020 events19 affected337 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (13.0)	EG0009 events4 affected337 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (13.0)	EG0007 events7 affected337 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	EG0008 events6 affected337 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	EG0009 events9 affected337 at risk
Dizziness	Nervous system disorders	MedDRA (13.0)	EG00011 events11 affected337 at risk
Headache	Nervous system disorders	MedDRA (13.0)	EG00028 events24 affected337 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	EG0008 events7 affected337 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	EG0004 events4 affected337 at risk
Hypertension	Vascular disorders	MedDRA (13.0)	EG0005 events5 affected337 at risk
Dysgeusia	Nervous system disorders	MedDRA (13.0)	EG0007 events4 affected337 at risk

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000090463	Iron Deficiencies
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D005290	Ferric Compounds
D058085	Iron Compounds
D007287	Inorganic Chemicals
D005296	Ferrous Compounds
D008903	Minerals