FIRST: A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

• Sponsor: AMAG Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01052779
• Collaborator: (none)
• Enrollment: 162
• Locations: 36
• Arms: 2
• Actual Duration (Months): 25.6
• Patients Per Site: 4.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency; Anemia; Kidney Disease	Drug: Ferumoxytol; Drug: Iron Sucrose	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease
• Actual Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jul 19, 2011
• Actual Study Completion Date: Apr 19, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ferumoxytol 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; IV Ferumoxytol; Other Names: Feraheme
Active Comparator: 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.	Drug: Iron Sucrose; IV Iron Sucrose; Other Names: Venofer

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Key Inclusion Criteria include:

1. Males and females ≥18 years of age

2. An estimated glomerular filtration rate <60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis)

3. Hemoglobin <11.0 g/deciliter (dL)

4. Transferrin saturation <30%

5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week

6. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of the study

Exclusion Criteria:

Key Exclusion Criteria include:

1. History of allergy to IV iron

2. Allergy to 2 or more classes of drugs

3. Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test

4. Hemoglobin ≤7.0 g/dL

5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period

6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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	United States	85284
2	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.	Chula Vista	California	United States	91910
3	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.	Mountain View	California	United States	94041
4	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.	Whittier	California	United States	90602
5	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.	Augusta	Georgia	United States	30901
6	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.	Meridian	Idaho	United States	83642
7	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.	Evergreen Park	Illinois	United States	60805
8	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.	Shreveport	Louisiana	United States	71101
9	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.	Bethesda	Maryland	United States
10	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.	Springfield	Massachusetts	United States	01107
11	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.	Flushing	New York	United States	11355
12	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.	Rosedale	New York	United States
13	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.	Bethlehem	Pennsylvania	United States	18017
14	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.	San Antonio	Texas	United States	78229
15	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Antwerpen		Belgium	2020
16	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Antwerpen		Belgium	2060
17	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.	Vancouver	British Columbia	Canada
18	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.	Richmond Hill	Ontario	Canada
19	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.	Montréal	Quebec	Canada	H3A 1A1
20	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.	Montréal	Quebec	Canada	H4J 1C5
21	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Berlin		Germany
22	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Düsseldorf		Germany
23	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Göttingen		Germany
24	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Munich		Germany
25	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nürnberg		Germany
26	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Passau		Germany
27	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bangalore		India
28	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nagpur		India
29	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Pune		India
30	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Katowice		Poland
31	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Opole		Poland
32	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Radom		Poland
33	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Szczecin		Poland
34	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Warszawa		Poland
35	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Łódź		Poland
36	For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	London		United Kingdom

Sponsors and Collaborators

• AMAG Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Strauss WE, Dahl NV, Li Z, Lau G, Allen LF. Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia. BMC Hematol. 2016 Jul 26;16:20. doi: 10.1186/s12878-016-0060-x. eCollection 2016.

• Responsible Party: AMAG Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01052779
• Other Study ID Numbers: FER-CKD-201; 2009-015630-30
• First Posted: Jan 20, 2010
• Last Update Posted: May 15, 2018
• Last Verified: May 1, 2018

• Keywords provided by AMAG Pharmaceuticals, Inc.: Iron deficiency anemia; Chronic kidney disease; Feraheme; Ferumoxytol; Iron sucrose; IDA; CKD; Venofer
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Ferrosoferric Oxide; Ferric Oxide, Saccharated

Study Results

Participant Flow

Arm/Group Title	Ferumoxytol	Iron Sucrose
Arm/Group Description	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).	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.
Period Title: Overall Study
STARTED	80	82
Received at Least 1 Dose of Study Drug	80	81
COMPLETED	75	73
NOT COMPLETED	5	9

Baseline Characteristics

Arm/Group Title	Ferumoxytol	Iron Sucrose	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	80	82	162
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.9 (15.00)	63.3 (15.16)	62.6 (15.05)
Sex: Female, Male (Count of Participants)
Female	41 51.3%	39 47.6%	80 49.4%
Male	39 48.8%	43 52.4%	82 50.6%
Dialysis Status (Count of Participants)
Hemodialysis	34 42.5%	36 43.9%	70 43.2%
Nondialysis	46 57.5%	46 56.1%	92 56.8%

Outcome Measures

1. Primary Outcome

Title	Mean Change In Hemoglobin From Baseline (Day 1) To Week 5
Description	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.
Time Frame	Baseline (Day 1), Week 5

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ferumoxytol	Iron Sucrose
Arm/Group Description	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.	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.
Measure Participants	80	82
With LOCF Imputation	0.84 (0.14)	0.74 (0.14)
Without Imputation (Sensitivity Analysis)	0.89 (0.15)	0.80 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ferumoxytol, Iron Sucrose
	Comments	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.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.
Statistical Test of Hypothesis	p-Value	0.515
	Comments	The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 95%; -0.21 to 0.41
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ferumoxytol, Iron Sucrose
	Comments	Without Imputation (Sensitivity Analysis): The p-value and two-sided 95% CI for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an ANOVA model adjusted for baseline hemoglobin level and hemodialysis status.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.
Statistical Test of Hypothesis	p-Value	0.587
	Comments	The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; -0.23 to 0.41
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.

2. Primary Outcome

Title	Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5
Description	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).
Time Frame	Baseline (Day 1) and up to Week 5

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ferumoxytol	Iron Sucrose
Arm/Group Description	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.	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.
Measure Participants	80	82
Week 2	20 25%	11 13.4%
Week 3	32 40%	20 24.4%
Week 4	37 46.3%	31 37.8%
Week 5	40 50%	34 41.5%

Adverse Events

Arm/Group Title	Ferumoxytol		Iron Sucrose
Arm/Group Description	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.		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.
All Cause Mortality
	Ferumoxytol		Iron Sucrose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ferumoxytol		Iron Sucrose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/80 (8.8%)		6/82 (7.3%)
Gastrointestinal disorders
Abdominal pain	1/80 (1.3%)		0/82 (0%)
Peritoneal adhesions	1/80 (1.3%)		0/82 (0%)
Small intestinal obstruction	1/80 (1.3%)		0/82 (0%)
Immune system disorders
Anaphylactic reaction	1/80 (1.3%)		0/82 (0%)
Infections and infestations
Abscess limb	0/80 (0%)		1/82 (1.2%)
Arteriovenous graft site infection	0/80 (0%)		1/82 (1.2%)
Cellulitis	0/80 (0%)		1/82 (1.2%)
Gastroenteritis	1/80 (1.3%)		0/82 (0%)
Pneumonia	0/80 (0%)		1/82 (1.2%)
Urinary tract infection	0/80 (0%)		1/82 (1.2%)
Injury, poisoning and procedural complications
Anastomotic haemorrhage	1/80 (1.3%)		0/82 (0%)
Seroma	0/80 (0%)		1/82 (1.2%)
Vascular graft thrombosis	0/80 (0%)		1/82 (1.2%)
Metabolism and nutrition disorders
Hyperkalaemia	0/80 (0%)		1/82 (1.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm	0/80 (0%)		1/82 (1.2%)
Renal and urinary disorders
Acute prerenal failure	1/80 (1.3%)		0/82 (0%)
Renal failure chronic	0/80 (0%)		1/82 (1.2%)
Vascular disorders
Deep vein thrombosis	1/80 (1.3%)		0/82 (0%)
Hypotension	0/80 (0%)		1/82 (1.2%)
Other (Not Including Serious) Adverse Events
	Ferumoxytol		Iron Sucrose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/80 (43.8%)		50/82 (61%)
Blood and lymphatic system disorders
Anaemia	2/80 (2.5%)		1/82 (1.2%)
Iron deficiency anaemia	0/80 (0%)		1/82 (1.2%)
Ear and labyrinth disorders
Cerumen impaction	0/80 (0%)		1/82 (1.2%)
Eye disorders
Lacrimation increased	0/80 (0%)		1/82 (1.2%)
Gastrointestinal disorders
Constipation	2/80 (2.5%)		3/82 (3.7%)
Diarrhoea	2/80 (2.5%)		1/82 (1.2%)
Nausea	6/80 (7.5%)		3/82 (3.7%)
Vomiting	1/80 (1.3%)		2/82 (2.4%)
Abdominal pain upper	1/80 (1.3%)		0/82 (0%)
Tooth disorder	1/80 (1.3%)		0/82 (0%)
Toothache	1/80 (1.3%)		0/82 (0%)
General disorders
Injection site pain	1/80 (1.3%)		2/82 (2.4%)
Edema peripheral	2/80 (2.5%)		6/82 (7.3%)
Catheter site erythema	1/80 (1.3%)		0/82 (0%)
Feeling hot	1/80 (1.3%)		1/82 (1.2%)
Injection site haematoma	1/80 (1.3%)		0/82 (0%)
Tenderness	1/80 (1.3%)		0/82 (0%)
Chills	0/80 (0%)		1/82 (1.2%)
Device leakage	0/80 (0%)		1/82 (1.2%)
Fatigue	0/80 (0%)		1/82 (1.2%)
Feeling cold	0/80 (0%)		1/82 (1.2%)
Injection site haemorrhage	0/80 (0%)		1/82 (1.2%)
Medical device complication	0/80 (0%)		1/82 (1.2%)
Thrombosis in device	0/80 (0%)		1/82 (1.2%)
Infections and infestations
Nasopharyngitis	3/80 (3.8%)		2/82 (2.4%)
Urinary tract infection	3/80 (3.8%)		5/82 (6.1%)
Sinusitis	1/80 (1.3%)		0/82 (0%)
Staphylococcal abscess	1/80 (1.3%)		0/82 (0%)
Urethritis	0/80 (0%)		1/82 (1.2%)
Injury, poisoning and procedural complications
Burn first degree	1/80 (1.3%)		0/82 (0%)
Humerus fracture	1/80 (1.3%)		0/82 (0%)
Procedural hypotension	1/80 (1.3%)		0/82 (0%)
Vascular graft thrombosis	1/80 (1.3%)		0/82 (0%)
Arthropod bite	0/80 (0%)		1/82 (1.2%)
Fall	0/80 (0%)		1/82 (1.2%)
Procedural hypertension	0/80 (0%)		1/82 (1.2%)
Scratch	0/80 (0%)		1/82 (1.2%)
Sunburn	0/80 (0%)		1/82 (1.2%)
Investigations
Blood glucose increased	1/80 (1.3%)		0/82 (0%)
Breath sounds abnormal	1/80 (1.3%)		0/82 (0%)
Weight increased	1/80 (1.3%)		0/82 (0%)
Blood pressure increased	0/80 (0%)		1/82 (1.2%)
Cardiac murmur	0/80 (0%)		1/82 (1.2%)
Hepatic enzyme increased	0/80 (0%)		1/82 (1.2%)
Metabolism and nutrition disorders
Hyperkalaemia	3/80 (3.8%)		0/82 (0%)
Hypoglycaemia	2/80 (2.5%)		3/82 (3.7%)
Gout	1/80 (1.3%)		3/82 (3.7%)
Hyperglycaemia	1/80 (1.3%)		1/82 (1.2%)
Hyperkalaemia	0/80 (0%)		1/82 (1.2%)
Vitamin D deficiency	0/80 (0%)		1/82 (1.2%)
Musculoskeletal and connective tissue disorders
Muscle spasms	4/80 (5%)		6/82 (7.3%)
Myalgia	0/80 (0%)		2/82 (2.4%)
Pain in extremity	1/80 (1.3%)		2/82 (2.4%)
Flank pain	1/80 (1.3%)		1/82 (1.2%)
Back pain	0/80 (0%)		1/82 (1.2%)
Bone pain	0/80 (0%)		1/82 (1.2%)
Limb discomfort	0/80 (0%)		1/82 (1.2%)
Neck pain	0/80 (0%)		1/82 (1.2%)
Synovial cyst	0/80 (0%)		1/82 (1.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis	0/80 (0%)		1/82 (1.2%)
Nervous system disorders
Headache	3/80 (3.8%)		2/82 (2.4%)
Parosmia	0/80 (0%)		4/82 (4.9%)
Dizziness	1/80 (1.3%)		2/82 (2.4%)
Dysgeusia	1/80 (1.3%)		1/82 (1.2%)
Facial palsy	1/80 (1.3%)		1/82 (1.2%)
Paraesthesia	1/80 (1.3%)		1/82 (1.2%)
Unresponsive to stimuli	0/80 (0%)		1/82 (1.2%)
Renal and urinary disorders
Haematuria	1/80 (1.3%)		0/82 (0%)
Nocturia	0/80 (0%)		1/82 (1.2%)
Respiratory, thoracic and mediastinal disorders
Cough	3/80 (3.8%)		0/82 (0%)
Asthma	1/80 (1.3%)		0/82 (0%)
Oropharyngeal pain	1/80 (1.3%)		0/82 (0%)
Dyspnoea	0/80 (0%)		1/82 (1.2%)
Epistaxis	0/80 (0%)		1/82 (1.2%)
Rales	0/80 (0%)		1/82 (1.2%)
Wheezing	0/80 (0%)		1/82 (1.2%)
Skin and subcutaneous tissue disorders
Ingrowing nail	1/80 (1.3%)		1/82 (1.2%)
Acne	0/80 (0%)		1/82 (1.2%)
Cold sweat	0/80 (0%)		1/82 (1.2%)
Dry skin	0/80 (0%)		1/82 (1.2%)
Ecchymosis	0/80 (0%)		1/82 (1.2%)
Skin haemorrhage	0/80 (0%)		1/82 (1.2%)
Social circumstances
Treatment noncompliance	0/80 (0%)		1/82 (1.2%)
Vascular disorders
Hypotension	2/80 (2.5%)		8/82 (9.8%)
Flushing	1/80 (1.3%)		0/82 (0%)
Hot flush	1/80 (1.3%)		0/82 (0%)
Hypertension	1/80 (1.3%)		1/82 (1.2%)
Poor veneous access	0/80 (0%)		1/82 (1.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If there is no multi-site publication within 18 months after the Study has been completed or terminated at all Study sites, and all data has been received by Sponsor, the Site and SMO shall have the right to publish its results from the Study for non-commercial purposes, if submitted to Sponsor for review 60 days prior to submission of publication. Publication must remove all confidential information and may be delayed by up to 180 days to allow Sponsor to protect its interests.