A Trial Comparing Ferumoxytol to Iron Sucrose for the Tre... | NCT01052779

ID	Type	Description	Link
2009-015630-30	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ferumoxytol	Experimental	Participants received an IV injection of ferumoxytol (510 milligrams [mg], 17 milliliters [mL]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).	Drug: Ferumoxytol
Iron Sucrose	Active Comparator	Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.	Drug: Iron Sucrose

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 Baseline (Day 1) To Week 5	The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline) The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method.	Baseline (Day 1), Week 5
Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5	The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).	Baseline (Day 1) and up to Week 5

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Tempe	Arizona	85284	United States

PubMed Identifier	Type	Citation	Retractions
24639149	Background	Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014 Jun;89(6):646-50. doi: 10.1002/ajh.23712.
27462400	Background

ID	Title	Description
FG000	Ferumoxytol	Participants received an intravenous (IV) injection of ferumoxytol (510 milligrams [mg], 17 milliliters [mL]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change In Hemoglobin From Baseline (Day 1) To Week 5

The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as:

Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline)

The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method.

ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose).

Posted

Least Squares Mean

Standard Error

g/dL

Baseline (Day 1), Week 5

ID	Title	Description
OG000	Ferumoxytol	Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
OG001	Iron Sucrose	Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

Units	Counts
Participants	OG00080 OG00182

Title

Denominators

Categories

With LOCF Imputation

Title	Measurements
	OG0000.84± 0.14 OG0010.74± 0.14

Without Imputation (Sensitivity Analysis)

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	With LOCF Imputation: The p-value and two-sided 95% confidence interval (CI) for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an analysis of variance (ANOVA) model adjusted for baseline hemoglobin level and hemodialysis status.	ANOVA		0.515	The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.	Treatment Difference	0.10			2-Sided	95	-0.21	0.41			The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.

Primary

Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5

The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).

ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose).

Posted

Count of Participants

Participants

Baseline (Day 1) and up to Week 5

ID	Title	Description
OG000	Ferumoxytol	Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
OG001	Iron Sucrose	Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 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 injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.			7	80	35	80
EG001	Iron Sucrose	Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.			6	82	50	82

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Abscess limb	Infections and infestations	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Cellulitis	Infections and infestations	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Anastomotic haemorrhage	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Peritoneal adhesions	Gastrointestinal disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Hypotension	Vascular disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 13.0	EG0003 affected80 at risk EG0012 affected82 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	EG0003 affected80 at risk EG0015 affected82 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0004 affected80 at risk EG0016 affected82 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0000 affected80 at risk EG0012 affected82 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0001 affected80 at risk EG0012 affected82 at risk
Injection site pain	General disorders	MedDRA 13.0	EG0001 affected80 at risk EG0012 affected82 at risk
Edema peripheral	General disorders	MedDRA 13.0	EG0002 affected80 at risk EG0016 affected82 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.0	EG0002 affected80 at risk EG0013 affected82 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	EG0002 affected80 at risk EG0011 affected82 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	EG0006 affected80 at risk EG0013 affected82 at risk
Headache	Nervous system disorders	MedDRA 13.0	EG0003 affected80 at risk EG0012 affected82 at risk
Parosmia	Nervous system disorders	MedDRA 13.0	EG0000 affected80 at risk EG0014 affected82 at risk
Hypotension	Vascular disorders	MedDRA 13.0	EG0002 affected80 at risk EG0018 affected82 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.0	EG0003 affected80 at risk EG0010 affected82 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	EG0002 affected80 at risk EG0013 affected82 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	EG0003 affected80 at risk EG0010 affected82 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	EG0002 affected80 at risk EG0011 affected82 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	EG0001 affected80 at risk EG0012 affected82 at risk
Gout	Metabolism and nutrition disorders	MedDRA 13.0	EG0001 affected80 at risk EG0013 affected82 at risk
Dizziness	Nervous system disorders	MedDRA 13.0	EG0001 affected80 at risk EG0012 affected82 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Lacrimation increased	Eye disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Toothache	Gastrointestinal disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Catheter site erythema	General disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Feeling hot	General disorders	MedDRA 13.0	EG0001 affected80 at risk EG0011 affected82 at risk
Injection site haematoma	General disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Tenderness	General disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Chills	General disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Device leakage	General disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Fatigue	General disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Feeling cold	General disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Injection site haemorrhage	General disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Medical device complication	General disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Thrombosis in device	General disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Sinusitis	Infections and infestations	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Staphylococcal abscess	Infections and infestations	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Urethritis	Infections and infestations	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Burn first degree	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Procedural hypertension	Injury, poisoning and procedural complications	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	EG0001 affected80 at risk EG0011 affected82 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0001 affected80 at risk EG0011 affected82 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Dysgeusia	Nervous system disorders	MedDRA 13.0	EG0001 affected80 at risk EG0011 affected82 at risk
Facial palsy	Nervous system disorders	MedDRA 13.0	EG0001 affected80 at risk EG0011 affected82 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.0	EG0001 affected80 at risk EG0011 affected82 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Haematuria	Renal and urinary disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Nocturia	Renal and urinary disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 13.0	EG0001 affected80 at risk EG0011 affected82 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Skin haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Treatment noncompliance	Social circumstances	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Flushing	Vascular disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Hot flush	Vascular disorders	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Hypertension	Vascular disorders	MedDRA 13.0	EG0001 affected80 at risk EG0011 affected82 at risk
Poor veneous access	Vascular disorders	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Blood glucose increased	Investigations	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Breath sounds abnormal	Investigations	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Weight increased	Investigations	MedDRA 13.0	EG0001 affected80 at risk EG0010 affected82 at risk
Blood pressure increased	Investigations	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Cardiac murmur	Investigations	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk
Hepatic enzyme increased	Investigations	MedDRA 13.0	EG0000 affected80 at risk EG0011 affected82 at risk

ID	Term
D000090463	Iron Deficiencies
D000740	Anemia
D007674	Kidney Diseases
D018798	Anemia, Iron-Deficiency
D051436	Renal Insufficiency, Chronic

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D000747	Anemia, Hypochromic
D051437	Renal Insufficiency
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D052203	Ferrosoferric Oxide
D000077605	Ferric Oxide, Saccharated

ID	Term
D005290	Ferric Compounds
D058085	Iron Compounds
D007287	Inorganic Chemicals
D005296	Ferrous Compounds
D008903	Minerals
D005937	Glucaric Acid
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D006880	Hydroxy Acids
D002241	Carbohydrates

ID	Title	Description
BG000	Ferumoxytol	Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
BG001	Iron Sucrose	Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.
BG002	Total	Total of all reporting groups