Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis

• Sponsor: AMAG Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01227616
• Collaborator: (none)
• Enrollment: 296
• Locations: 43
• Arms: 2
• Actual Duration (Months): 42.1
• Patients Per Site: 6.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia Treatment; Chronic Kidney Disease(CKD)	Drug: Ferumoxytol; Drug: Iron Sucrose	Phase 4

Detailed Description

This was a Phase IV, randomized, open-label, active-controlled, multicenter clinical trial designed to evaluate the safety, efficacy, and frequency of use of ferumoxytol compared to iron sucrose for the episodic treatment of IDA in hemodialysis subjects with CKD over a 1-year period. As part of this Main Study, an Oxidative Stress Substudy and an MRI Substudy were conducted. The Oxidative Stress Substudy, to be run concurrently with the initial TP of the Main Study, was to examine the varying degrees to which iron sucrose and ferumoxytol may or may not induce oxidative stress in vitro in subjects undergoing hemodialysis. The MRI Substudy, to be run concurrently with the Main Study and continue for an additional 11 months, was to assess the potential for deposition of iron in cardiac, hepatic, and pancreatic tissues and changes in laboratory parameters over a 2-year period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 296 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, With MRI Substudy, of Repeated Doses of Ferumoxytol Compared With Iron Sucrose for Treatment of IDA in CKD Patients on Hemodialysis
• Actual Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ferumoxytol Intravenous (IV) iron	Drug: Ferumoxytol; IV Ferumoxytol; Other Names: Feraheme
Active Comparator: IV Iron Sucrose Intravenous (IV) iron	Drug: Iron Sucrose; IV Iron Sucrose; Other Names: Venofer

Outcome Measures

Primary Outcome Measures

1. Hemoglobin Changes [Up to 6 treatment periods (5 weeks per treatment period)]

   Changes in the mean hemoglobin between Baseline and Week 5 for ferumoxytol and iron sucrose in each treatment period.

Secondary Outcome Measures

1. Changes in Transferrin Saturation (TSAT) [Up to 6 treatment periods (5 weeks per treatment period)]

   Mean change in TSAT from TP Baseline to Week 5 for each TP

2. Proportion of Subjects With an Increase in Hemoglobin of ≥1.0 g/dL at Any Time From TP Baseline to Week 5 for Each TP [Up to 6 treatment periods (5 weeks per treatment period)]

   The proportion of subjects by group achieving a ≥1.0 g/dL increase in hemoglobin at any point during each 5-week treatment period.

Eligibility Criteria

Criteria

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

Key Inclusion Criteria include:

1. Males and females ≥18 years of age

2. Diagnosis of CKD

3. Subjects on dialysis must have been on dialysis for at least 3 months prior to screening

4. Female subjects 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 participation in the study

Key Exclusion Criteria include:

1. History of allergy to either oral or IV iron

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

3. Parenteral iron therapy within 30 days prior to screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to screening or planned during the study

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	Pine Bluff	Arkansas	United States	71603
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	Azusa	California	United States	91702
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	Beverly Hills	California	United States	90211
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	Los Angeles	California	United States	90022
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	Los Angeles	California	United States	90095
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	Lynwood	California	United States	90262
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	Northridge	California	United States	91324
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	Paramount	California	United States	90723
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	Sacramento	California	United States	95815
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	San Diego	California	United States	92123
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	San Gabriel	California	United States	91776
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	Simi Valley	California	United States	93065
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	Whittier	California	United States	90603
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	Whittier	California	United States	90603
15	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	Middlebury	Connecticut	United States	06762
16	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	Coral Springs	Florida	United States	33071
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	Miami	Florida	United States	33186
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	Augusta	Georgia	United States	30904
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	Macon	Georgia	United States	31217
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	Louisville	Kentucky	United States	40292
21	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	New Orleans	Louisiana	United States	70112
22	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	71103
23	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	Framingham	Massachusetts	United States	01702
24	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	Pontiac	Michigan	United States	48341
25	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	Roseville	Michigan	United States	48066
26	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	Farmington	Missouri	United States	63640
27	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	Bronx	New York	United States	10641
28	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	Brooklyn	New York	United States	11212
29	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	Ridgewood	New York	United States	11385
30	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	Asheville	North Carolina	United States	28805
31	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
32	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	Philadelphia	Pennsylvania	United States	19144
33	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	Columbia	South Carolina	United States	29209
34	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	Arlington	Texas	United States	76015
35	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	Edinburg	Texas	United States	78539
36	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	Houston	Texas	United States	78238
37	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	78205
38	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
39	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		Canada
40	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		Canada
41	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	Toronto		Canada
42	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	London		United Kingdom
43	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	London		United Kingdom

Sponsors and Collaborators

• AMAG Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AMAG Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01227616
• Other Study ID Numbers: AMAG-FER-CKD-401
• First Posted: Oct 25, 2010
• Last Update Posted: Apr 21, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by AMAG Pharmaceuticals, Inc.: Iron deficiency anemia (IDA); chronic kidney disease (CKD); hemodialysis; magnetic resonance imaging (MRI); ferumoxytol; Feraheme
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Ferrosoferric Oxide; Ferric Oxide, Saccharated

Study Results

Participant Flow

Pre-assignment Detail	A total of 296 hemodialysis patients with IDA who met the entry criteria were enrolled and randomized (ferumoxytol: n=197; iron sucrose: n=99). One subject in the ferumoxytol group and 2 subjects in the iron sucrose group withdrew prior to receiving study drug, resulting in 293 total participants for analysis.

Arm/Group Title	Ferumoxytol	Iron Sucrose
Arm/Group Description	30 mg Fe/mL for IV injection	20 mg Fe/mL for IV injection
Period Title: Overall Study
STARTED	196	97
COMPLETED	142	74
NOT COMPLETED	54	23

Baseline Characteristics

Arm/Group Title	Ferumoxytol	Iron Sucrose	Total
Arm/Group Description	30 mg Fe/mL for IV injection	20 mg Fe/mL for IV injection	Total of all reporting groups
Overall Participants	196	97	293
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.3 (14.13)	57.6 (13.62)	58.8 (13.96)
Sex: Female, Male (Count of Participants)
Female	82 41.8%	40 41.2%	122 41.6%
Male	114 58.2%	57 58.8%	171 58.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	68 34.7%	40 41.2%	108 36.9%
Not Hispanic or Latino	128 65.3%	57 58.8%	185 63.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	10 5.1%	4 4.1%	14 4.8%
Asian	15 7.7%	13 13.4%	28 9.6%
Native Hawaiian or Other Pacific Islander	2 1%	3 3.1%	5 1.7%
Black or African American	62 31.6%	26 26.8%	88 30%
White	101 51.5%	47 48.5%	148 50.5%
More than one race	6 3.1%	4 4.1%	10 3.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	185 94.4%	90 92.8%	275 93.9%
Canada	5 2.6%	2 2.1%	7 2.4%
United Kingdom	6 3.1%	5 5.2%	11 3.8%
Mean Hemoglobin (g/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/dL]	10.4 (0.74)	10.4 (0.81)	10.4 (0.76)

Outcome Measures

1. Primary Outcome

Title	Hemoglobin Changes
Description	Changes in the mean hemoglobin between Baseline and Week 5 for ferumoxytol and iron sucrose in each treatment period.
Time Frame	Up to 6 treatment periods (5 weeks per treatment period)

Outcome Measure Data

Analysis Population Description

Mean Change in Hemoglobin at Week 5 - ITT Population

Arm/Group Title	Ferumoxytol	Iron Sucrose
Arm/Group Description	30 mg Fe/mL for IV injection	20 mg Fe/mL for IV injection
Measure Participants	196	97
TP1	0.5 (0.97)	0.4 (0.97)
TP2	0.6 (0.96)	0.3 (1.03)
TP3	0.6 (1.10)	0.4 (0.87)
TP4	0.5 (1.12)	0.6 (1.11)
TP5	0.4 (1.14)	0.3 (0.96)
TP6	0.5 (1.21)	-0.3 (1.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ferumoxytol
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The study protocol defined the margin for non-inferiority as 0.5 g/dL meaning non-inferiority would be established in a TP if the lower limit of the 95% confidence limit for the difference between ferumoxytol and iron sucrose mean change was ≥0.5 g/dL.
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANCOVA
	Comments	Stats. of primary endpoint performed only for TP1 and TP2. 240 subjects retreated should yield 90% power to detect non-inferiority during TP2.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Changes in Transferrin Saturation (TSAT)
Description	Mean change in TSAT from TP Baseline to Week 5 for each TP
Time Frame	Up to 6 treatment periods (5 weeks per treatment period)

Outcome Measure Data

Analysis Population Description

Mean Change in TSAT at Week 5 - ITT Population

Arm/Group Title	Ferumoxytol	Iron Sucrose
Arm/Group Description	30 mg Fe/mL for IV injection	20 mg Fe/mL for IV injection
Measure Participants	195	95
TP1	6.6 (9.2)	9.5 (11.97)
TP2	8.2 (12.95)	11.3 (14.68)
TP3	8.5 (10.56)	9.1 (11.13)
TP4	9.8 (14.76)	10.0 (14.76)
TP5	6.3 (9.77)	14.4 (17.05)
TP6	7.1 (16.62)	5.1 (12.84)

3. Secondary Outcome

Title	Proportion of Subjects With an Increase in Hemoglobin of ≥1.0 g/dL at Any Time From TP Baseline to Week 5 for Each TP
Description	The proportion of subjects by group achieving a ≥1.0 g/dL increase in hemoglobin at any point during each 5-week treatment period.
Time Frame	Up to 6 treatment periods (5 weeks per treatment period)

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Ferumoxytol	Iron Sucrose
Arm/Group Description	30 mg Fe/mL for IV injection	20 mg Fe/mL for IV injection
Measure Participants	196	97
TP1	55 28.1%	23 23.7%
TP2	55 28.1%	13 13.4%
TP3	42 21.4%	19 19.6%
TP4	20 10.2%	10 10.3%
TP5	13 6.6%	3 3.1%
TP6	5 2.6%	1 1%

Adverse Events

Time Frame	Reported Adverse Events (AEs) include events starting on or after day 0 up to 13 months
Adverse Event Reporting Description	Safety population included all patients who received any study drug.
Arm/Group Title	Ferumoxytol		Iron Sucrose
Arm/Group Description	30 mg Fe/mL for IV injection		20 mg Fe/mL for IV injection
All Cause Mortality
	Ferumoxytol		Iron Sucrose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/196 (8.2%)		6/97 (6.2%)
Serious Adverse Events
	Ferumoxytol		Iron Sucrose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	93/196 (47.4%)		49/97 (50.5%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	7/196 (3.6%)	8	5/97 (5.2%)	5
Anaemia	4/196 (2%)	5	4/97 (4.1%)	4
Cardiac disorders
Cardiac disorders	20/196 (10.2%)	31	15/97 (15.5%)	27
Cardiac failure congestive	5/196 (2.6%)	5	5/97 (5.2%)	7
Acute myocardial infarction	4/196 (2%)	4	3/97 (3.1%)	6
Angina pectoris	3/196 (1.5%)	4	4/97 (4.1%)	6
Cardiac arrest	3/196 (1.5%)	5	2/97 (2.1%)	2
Cardio-respiratory arrest	4/196 (2%)	4	1/97 (1%)	1
Ear and labyrinth disorders
Ear and labyrinth disorders	0/196 (0%)	0	2/97 (2.1%)	3
Gastrointestinal disorders
Gastrointestinal disorders	25/196 (12.8%)	32	12/97 (12.4%)	21
Abdominal pain	2/196 (1%)	2	4/97 (4.1%)	4
Gastrointestinal haemorrhage	3/196 (1.5%)	3	1/97 (1%)	1
Vomiting	1/196 (0.5%)	1	3/97 (3.1%)	3
Nausea	0/196 (0%)	0	3/97 (3.1%)	3
General disorders
General disorders and administration site conditions	9/196 (4.6%)	10	6/97 (6.2%)	6
Non-cardiac chest pain	5/196 (2.6%)	5	2/97 (2.1%)	2
Immune system disorders
Immune system disorders	2/196 (1%)	2	1/97 (1%)	1
Infections and infestations
Infections and infestations	38/196 (19.4%)	49	17/97 (17.5%)	24
Sepsis	10/196 (5.1%)	10	2/97 (2.1%)	2
Pneumonia	7/196 (3.6%)	7	3/97 (3.1%)	4
Cellulitis	4/196 (2%)	4	2/97 (2.1%)	2
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications	18/196 (9.2%)	22	16/97 (16.5%)	20
Arteriovenous fistula thrombosis	4/196 (2%)	5	4/97 (4.1%)	4
Hip fracture	3/196 (1.5%)	3	0/97 (0%)	0
Investigations
Investigations	0/196 (0%)	0	2/97 (2.1%)	2
Metabolism and nutrition disorders
Metabolism and nutrition disorders	17/196 (8.7%)	18	10/97 (10.3%)	21
Fluid overload	9/196 (4.6%)	10	4/97 (4.1%)	9
Hyperkalaemia	5/196 (2.6%)	5	4/97 (4.1%)	6
Hypoglycaemia	2/196 (1%)	2	3/97 (3.1%)	3
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	3/196 (1.5%)	6	3/97 (3.1%)	4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	2/196 (1%)	3	1/97 (1%)	1
Nervous system disorders
Nervous system disorders	13/196 (6.6%)	16	9/97 (9.3%)	12
Psychiatric disorders
Psychiatric disorders	6/196 (3.1%)	11	2/97 (2.1%)	3
Mental status changes	5/196 (2.6%)	10	1/97 (1%)	2
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	21/196 (10.7%)	27	6/97 (6.2%)	9
Acute respiratory failure	7/196 (3.6%)	7	2/97 (2.1%)	2
Pulmonary oedema	6/196 (3.1%)	7	2/97 (2.1%)	2
Dyspnoea	4/196 (2%)	4	1/97 (1%)	1
Pleural effusion	3/196 (1.5%)	4	0/97 (0%)	0
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders	1/196 (0.5%)	1	1/97 (1%)	1
Vascular disorders
Vascular disorders	12/196 (6.1%)	14	13/97 (13.4%)	14
Other (Not Including Serious) Adverse Events
	Ferumoxytol		Iron Sucrose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	158/196 (80.6%)		81/97 (83.5%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	14/196 (7.1%)	20	6/97 (6.2%)	6
Anaemia	8/196 (4.1%)	12	5/97 (5.2%)	5
Cardiac disorders
Cardiac disorders	30/196 (15.3%)	64	18/97 (18.6%)	33
Cardiac failure congestive	6/196 (3.1%)	6	5/97 (5.2%)	7
Gastrointestinal disorders
Gastrointestinal disorders	74/196 (37.8%)	163	36/97 (37.1%)	85
Nausea	22/196 (11.2%)	30	15/97 (15.5%)	17
Diarrhoea	21/196 (10.7%)	25	12/97 (12.4%)	13
Vomiting	16/196 (8.2%)	20	12/97 (12.4%)	15
Abdominal pain	12/196 (6.1%)	14	8/97 (8.2%)	9
General disorders and administration site conditions	57/196 (29.1%)	87	21/97 (21.6%)	37
General disorders
Non-cardiac chest pain	10/196 (5.1%)	11	7/97 (7.2%)	12
Pyrexia	15/196 (7.7%)	17	1/97 (1%)	1
Infections and infestations
Infections and infestations	64/196 (32.7%)	112	33/97 (34%)	61
Upper respiratory tract infection	14/196 (7.1%)	14	6/97 (6.2%)	7
Urinary tract infection	12/196 (6.1%)	12	3/97 (3.1%)	3
Pneumonia	11/196 (5.6%)	12	3/97 (3.1%)	4
Sepsis	10/196 (5.1%)	10	2/97 (2.1%)	2
Cellulitis	5/196 (2.6%)	5	6/97 (6.2%)	7
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications	61/196 (31.1%)	135	42/97 (43.3%)	101
Arteriovenous fistula site complication	14/196 (7.1%)	18	8/97 (8.2%)	25
Arteriovenous fistula thrombosis	7/196 (3.6%)	8	7/97 (7.2%)	7
Fall	7/196 (3.6%)	7	6/97 (6.2%)	6
Investigations
Investigations	11/196 (5.6%)	12	13/97 (13.4%)	21
Metabolism and nutrition disorders
Metabolism and nutrition disorders	32/196 (16.3%)	51	15/97 (15.5%)	29
Fluid overload	14/196 (7.1%)	15	6/97 (6.2%)	12
Hyperkalaemia	11/196 (5.6%)	11	5/97 (5.2%)	7
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	40/196 (20.4%)	127	25/97 (25.8%)	82
Pain in extremity	13/196 (6.6%)	16	11/97 (11.3%)	22
Muscle spasms	16/196 (8.2%)	70	7/97 (7.2%)	37
Arthralgia	8/196 (4.1%)	8	7/97 (7.2%)	10
Nervous system disorders
Nervous system disorders	35/196 (17.9%)	48	24/97 (24.7%)	48
Dizziness	10/196 (5.1%)	11	7/97 (7.2%)	18
Headache	8/196 (4.1%)	12	7/97 (7.2%)	9
Psychiatric disorders
Psychiatric disorders	18/196 (9.2%)	30	7/97 (7.2%)	11
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	41/196 (20.9%)	74	18/97 (18.6%)	30
Cough	12/196 (6.1%)	14	5/97 (5.2%)	5
Dyspnoea	11/196 (5.6%)	13	6/97 (6.2%)	6
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders	19/196 (9.7%)	32	10/97 (10.3%)	14
Pruritus	12/196 (6.1%)	15	4/97 (4.1%)	5
Vascular disorders
Vascular disorders	38/196 (19.4%)	77	24/97 (24.7%)	38
Hypotension	17/196 (8.7%)	21	7/97 (7.2%)	8
Hypertension	14/196 (7.1%)	37	6/97 (6.2%)	14

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 have 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.