A Phase III Safety Study of Ferumoxytol Compared to Ferri... | NCT02694978

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 an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter [mL]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.	Drug: Ferumoxytol
FCM	Active Comparator	Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.	Drug: FCM

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension	All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a >30% drop in systolic blood pressure from baseline or decrease of >20 mmHg for systolic blood pressure. Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.	Day 1 (after first dosing) through Week 5

Secondary Outcomes

Measure	Description	Time Frame
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death	All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Eligibility Module

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29417614	Background	Adkinson NF, Strauss WE, Macdougall IC, Bernard KE, Auerbach M, Kaper RF, Chertow GM, Krop JS. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial. Am J Hematol. 2018 May;93(5):683-690. doi: 10.1002/ajh.25060. Epub 2018 Feb 24.
29033620	Background

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ferumoxytol	Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter [mL]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Ferumoxytol	Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
BG001	Ferric Carboxymaltose (FCM)	Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
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

Moderate hypersensitivity reaction

Title	Measurements
	OG0003 OG0016

Severe hypersensitivity reaction

Title	Measurements
	OG000

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 OG001	Statistical analysis was only performed on composite reaction data (that is, the "Any TE moderate to severe hypersensitivity rxn" row in the data table).	Wald	The p-value was calculated using the Wald large sample assumption.	0.0001		Treatment difference	-0.10			2-Sided	95	-0.80	0.61					Non-Inferiority	The non-inferiority margin of 2.64% was used for the primary endpoint statistical analysis.

Secondary

Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death

A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment.

Posted

Count of Participants

Participants

Day 1 (after first dosing) through Week 5

ID	Title	Description
OG000	Ferumoxytol	Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
OG001	Ferric Carboxymaltose (FCM)	Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.

Secondary

Mean Change In Hemoglobin From Baseline To Week 5

Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.

Intent-to-treat (ITT) population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment.

Posted

Mean

Standard Deviation

g/dL

Baseline (Day 1), Week 5

ID	Title	Description
OG000	Ferumoxytol	Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
OG001	Ferric Carboxymaltose (FCM)	Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.

Secondary

Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5

Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.

ITT population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment.

Posted

Mean

Standard Deviation

g/dL

Baseline (Day 1), Week 5

ID	Title	Description
OG000	Ferumoxytol	Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
OG001	Ferric Carboxymaltose (FCM)	Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.

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	Ferumoxytol	Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.			36	997	186	997
EG001	Ferric Carboxymaltose (FCM)	Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.			35	1,000	245	1,000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Seizure	Nervous system disorders	MedDRA (19.0)	EG0002 affected997 at risk EG0010 affected1,000 at risk
Syncope	Nervous system disorders	MedDRA (19.0)	EG0003 affected997 at risk EG0013 affected1,000 at risk
Gastroenteritis	Infections and infestations	MedDRA (19.0)	EG0003 affected997 at risk EG0011 affected1,000 at risk
Pneumonia	Infections and infestations	MedDRA (19.0)	EG0002 affected997 at risk EG0010 affected1,000 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (19.0)	EG0002 affected997 at risk EG0010 affected1,000 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (19.0)	EG0002 affected997 at risk EG0010 affected1,000 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0011 affected1,000 at risk
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0013 affected1,000 at risk
Cardiorespiratory arrest	Cardiac disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Left ventricular failure	Cardiac disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Ascites	Gastrointestinal disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Joint abscess	Infections and infestations	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Anaphylactic reaction	Immune system disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Anal abscess	Infections and infestations	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Cellulitis	Infections and infestations	MedDRA (19.0)	EG0001 affected997 at risk EG0011 affected1,000 at risk
Sepsis	Infections and infestations	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Sepsis syndrome	Infections and infestations	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Anastomotic ulcer	Injury, poisoning and procedural complications	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0011 affected1,000 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	EG0001 affected997 at risk EG0011 affected1,000 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (19.0)	EG0001 affected743 at risk EG0010 affected776 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (19.0)	EG0001 affected743 at risk EG0010 affected776 at risk
Completed suicide	Psychiatric disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Rash maculopapular	Skin and subcutaneous tissue disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Aortic stenosis	Vascular disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Hypertensive crisis	Vascular disorders	MedDRA (19.0)	EG0001 affected997 at risk EG0010 affected1,000 at risk
Angina pectoris	Cardiac disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0012 affected1,000 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0012 affected1,000 at risk
Bipolar disorder	Psychiatric disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Restless legs syndrome	Nervous system disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Cardiac failure	Cardiac disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Chest pain	General disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Osteomyelitis	Infections and infestations	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Post-procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Metastatic uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	EG0000 affected743 at risk EG0011 affected776 at risk
Mixed hepatocellular cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
End stage renal disease	Renal and urinary disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Haematuria	Renal and urinary disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Aortic aneurysm	Vascular disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Hypertensive emergency	Vascular disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Hypotension	Vascular disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (19.0)	EG0000 affected997 at risk EG0011 affected1,000 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (19.0)	EG00035 affected997 at risk EG00160 affected1,000 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.0)	EG00029 affected997 at risk EG00133 affected1,000 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.0)	EG00017 affected997 at risk EG00121 affected1,000 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.0)	EG00014 affected997 at risk EG00113 affected1,000 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.0)	EG00011 affected997 at risk EG00113 affected1,000 at risk
Fatigue	General disorders	MedDRA (19.0)	EG00030 affected997 at risk EG00136 affected1,000 at risk
Chest discomfort	General disorders	MedDRA (19.0)	EG0008 affected997 at risk EG00111 affected1,000 at risk
Pyrexia	General disorders	MedDRA (19.0)	EG0007 affected997 at risk EG00122 affected1,000 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (19.0)	EG0000 affected997 at risk EG00118 affected1,000 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	EG00019 affected997 at risk EG00116 affected1,000 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	EG00014 affected997 at risk EG00112 affected1,000 at risk
Headache	Nervous system disorders	MedDRA (19.0)	EG00060 affected997 at risk EG00182 affected1,000 at risk
Dizziness	Nervous system disorders	MedDRA (19.0)	EG00025 affected997 at risk EG00140 affected1,000 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	EG00015 affected997 at risk EG00113 affected1,000 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	EG00011 affected997 at risk EG00118 affected1,000 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (19.0)	EG00012 affected997 at risk EG00111 affected1,000 at risk
Flushing	Vascular disorders	MedDRA (19.0)	EG00011 affected997 at risk EG00116 affected1,000 at risk
Hypertension	Vascular disorders	MedDRA (19.0)	EG0007 affected997 at risk EG00115 affected1,000 at risk
Chest pain	General disorders	MedDRA (19.0)	EG00010 affected997 at risk EG0014 affected1,000 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (19.0)	EG0003 affected997 at risk EG00113 affected1,000 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