Trial Outcomes & Findings for A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease (NCT NCT01052779)
NCT ID: NCT01052779
Last Updated: 2023-07-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
162 participants
Primary outcome timeframe
Baseline (Day 1), Week 5
Results posted on
2023-07-25
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
82
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
80
|
81
|
|
Overall Study
COMPLETED
|
75
|
73
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Other-Protocol Violation
|
1
|
1
|
|
Overall Study
Other-Surgery
|
0
|
2
|
|
Overall Study
Other-Missed Week 5 Visit
|
2
|
0
|
Baseline Characteristics
A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Ferumoxytol
n=80 Participants
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.
|
Iron Sucrose
n=82 Participants
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
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 15.00 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 15.16 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 15.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Dialysis Status
Hemodialysis
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Dialysis Status
Nondialysis
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Week 5Population: ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose).
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.
Outcome measures
| Measure |
Ferumoxytol
n=80 Participants
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.
|
Iron Sucrose
n=82 Participants
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.
|
|---|---|---|
|
Mean Change In Hemoglobin From Baseline (Day 1) To Week 5
With LOCF Imputation
|
0.84 g/dL
Standard Error 0.14
|
0.74 g/dL
Standard Error 0.14
|
|
Mean Change In Hemoglobin From Baseline (Day 1) To Week 5
Without Imputation (Sensitivity Analysis)
|
0.89 g/dL
Standard Error 0.15
|
0.80 g/dL
Standard Error 0.15
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to Week 5Population: ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose).
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).
Outcome measures
| Measure |
Ferumoxytol
n=80 Participants
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.
|
Iron Sucrose
n=82 Participants
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.
|
|---|---|---|
|
Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5
Week 2
|
20 Participants
|
11 Participants
|
|
Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5
Week 3
|
32 Participants
|
20 Participants
|
|
Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5
Week 4
|
37 Participants
|
31 Participants
|
|
Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5
Week 5
|
40 Participants
|
34 Participants
|
Adverse Events
Ferumoxytol
Serious events: 7 serious events
Other events: 35 other events
Deaths: 0 deaths
Iron Sucrose
Serious events: 6 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferumoxytol
n=80 participants at risk
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.
|
Iron Sucrose
n=82 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Abscess limb
|
0.00%
0/80
|
1.2%
1/82
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.00%
0/80
|
1.2%
1/82
|
|
Infections and infestations
Cellulitis
|
0.00%
0/80
|
1.2%
1/82
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/80
|
0.00%
0/82
|
|
Infections and infestations
Pneumonia
|
0.00%
0/80
|
1.2%
1/82
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/80
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
1.2%
1/80
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/80
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/80
|
1.2%
1/82
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/80
|
0.00%
0/82
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
1.2%
1/80
|
0.00%
0/82
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.2%
1/80
|
0.00%
0/82
|
|
Renal and urinary disorders
Acute prerenal failure
|
1.2%
1/80
|
0.00%
0/82
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/80
|
1.2%
1/82
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/80
|
0.00%
0/82
|
|
Vascular disorders
Hypotension
|
0.00%
0/80
|
1.2%
1/82
|
|
Immune system disorders
Anaphylactic reaction
|
1.2%
1/80
|
0.00%
0/82
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/80
|
1.2%
1/82
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/80
|
1.2%
1/82
|
Other adverse events
| Measure |
Ferumoxytol
n=80 participants at risk
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.
|
Iron Sucrose
n=82 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.8%
3/80
|
2.4%
2/82
|
|
Infections and infestations
Urinary tract infection
|
3.8%
3/80
|
6.1%
5/82
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
4/80
|
7.3%
6/82
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/80
|
2.4%
2/82
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/80
|
2.4%
2/82
|
|
General disorders
Injection site pain
|
1.2%
1/80
|
2.4%
2/82
|
|
General disorders
Edema peripheral
|
2.5%
2/80
|
7.3%
6/82
|
|
Gastrointestinal disorders
Constipation
|
2.5%
2/80
|
3.7%
3/82
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
2/80
|
1.2%
1/82
|
|
Gastrointestinal disorders
Nausea
|
7.5%
6/80
|
3.7%
3/82
|
|
Nervous system disorders
Headache
|
3.8%
3/80
|
2.4%
2/82
|
|
Nervous system disorders
Parosmia
|
0.00%
0/80
|
4.9%
4/82
|
|
Vascular disorders
Hypotension
|
2.5%
2/80
|
9.8%
8/82
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/80
|
1.2%
1/82
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.5%
2/80
|
3.7%
3/82
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
3/80
|
0.00%
0/82
|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
2/80
|
1.2%
1/82
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/80
|
2.4%
2/82
|
|
Metabolism and nutrition disorders
Gout
|
1.2%
1/80
|
3.7%
3/82
|
|
Nervous system disorders
Dizziness
|
1.2%
1/80
|
2.4%
2/82
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/80
|
1.2%
1/82
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/80
|
1.2%
1/82
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/80
|
1.2%
1/82
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
1/80
|
0.00%
0/82
|
|
Gastrointestinal disorders
Tooth disorder
|
1.2%
1/80
|
0.00%
0/82
|
|
Gastrointestinal disorders
Toothache
|
1.2%
1/80
|
0.00%
0/82
|
|
General disorders
Catheter site erythema
|
1.2%
1/80
|
0.00%
0/82
|
|
General disorders
Feeling hot
|
1.2%
1/80
|
1.2%
1/82
|
|
General disorders
Injection site haematoma
|
1.2%
1/80
|
0.00%
0/82
|
|
General disorders
Tenderness
|
1.2%
1/80
|
0.00%
0/82
|
|
General disorders
Chills
|
0.00%
0/80
|
1.2%
1/82
|
|
General disorders
Device leakage
|
0.00%
0/80
|
1.2%
1/82
|
|
General disorders
Fatigue
|
0.00%
0/80
|
1.2%
1/82
|
|
General disorders
Feeling cold
|
0.00%
0/80
|
1.2%
1/82
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/80
|
1.2%
1/82
|
|
General disorders
Medical device complication
|
0.00%
0/80
|
1.2%
1/82
|
|
General disorders
Thrombosis in device
|
0.00%
0/80
|
1.2%
1/82
|
|
Infections and infestations
Sinusitis
|
1.2%
1/80
|
0.00%
0/82
|
|
Infections and infestations
Staphylococcal abscess
|
1.2%
1/80
|
0.00%
0/82
|
|
Infections and infestations
Urethritis
|
0.00%
0/80
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Burn first degree
|
1.2%
1/80
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.2%
1/80
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
1.2%
1/80
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
1.2%
1/80
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/80
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/80
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/80
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/80
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/80
|
1.2%
1/82
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.2%
1/80
|
1.2%
1/82
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/80
|
1.2%
1/82
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.2%
1/80
|
1.2%
1/82
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/80
|
1.2%
1/82
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/80
|
1.2%
1/82
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/80
|
1.2%
1/82
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/80
|
1.2%
1/82
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/80
|
1.2%
1/82
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/80
|
1.2%
1/82
|
|
Nervous system disorders
Dysgeusia
|
1.2%
1/80
|
1.2%
1/82
|
|
Nervous system disorders
Facial palsy
|
1.2%
1/80
|
1.2%
1/82
|
|
Nervous system disorders
Paraesthesia
|
1.2%
1/80
|
1.2%
1/82
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/80
|
1.2%
1/82
|
|
Renal and urinary disorders
Haematuria
|
1.2%
1/80
|
0.00%
0/82
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/80
|
1.2%
1/82
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
1/80
|
0.00%
0/82
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.2%
1/80
|
0.00%
0/82
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/80
|
1.2%
1/82
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/80
|
1.2%
1/82
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/80
|
1.2%
1/82
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/80
|
1.2%
1/82
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
1.2%
1/80
|
1.2%
1/82
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/80
|
1.2%
1/82
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/80
|
1.2%
1/82
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/80
|
1.2%
1/82
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/80
|
1.2%
1/82
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/80
|
1.2%
1/82
|
|
Social circumstances
Treatment noncompliance
|
0.00%
0/80
|
1.2%
1/82
|
|
Vascular disorders
Flushing
|
1.2%
1/80
|
0.00%
0/82
|
|
Vascular disorders
Hot flush
|
1.2%
1/80
|
0.00%
0/82
|
|
Vascular disorders
Hypertension
|
1.2%
1/80
|
1.2%
1/82
|
|
Vascular disorders
Poor veneous access
|
0.00%
0/80
|
1.2%
1/82
|
|
Investigations
Blood glucose increased
|
1.2%
1/80
|
0.00%
0/82
|
|
Investigations
Breath sounds abnormal
|
1.2%
1/80
|
0.00%
0/82
|
|
Investigations
Weight increased
|
1.2%
1/80
|
0.00%
0/82
|
|
Investigations
Blood pressure increased
|
0.00%
0/80
|
1.2%
1/82
|
|
Investigations
Cardiac murmur
|
0.00%
0/80
|
1.2%
1/82
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/80
|
1.2%
1/82
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER