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Iron Supplement

A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

Phase 3
Recruiting
Research Sponsored by AMAG Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 49 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new drug, ferumoxytol, to see if it is safe and effective in treating iron deficiency anemia or preventing it in children with CKD.

Eligible Conditions
  • Anemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~49 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 49 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5
Secondary study objectives
Incidence of Treatment Emergent Adverse Events
Incidence of adverse events of special interest (AESI)
Other study objectives
Area Under the Curve (AUC)
Clearance
Distribution and elimination half-lives

Side effects data

From 2017 Phase 4 trial • 296 Patients • NCT01227616
38%
Gastrointestinal disorders
33%
Infections and infestations
31%
Injury, poisoning and procedural complications
29%
General disorders and administration site conditions
21%
Respiratory, thoracic and mediastinal disorders
20%
Musculoskeletal and connective tissue disorders
19%
Vascular disorders
18%
Nervous system disorders
16%
Metabolism and nutrition disorders
15%
Cardiac disorders
11%
Nausea
11%
Diarrhoea
10%
Skin and subcutaneous tissue disorders
9%
Hypotension
9%
Psychiatric disorders
8%
Vomiting
8%
Muscle spasms
8%
Pyrexia
7%
Arteriovenous fistula site complication
7%
Upper respiratory tract infection
7%
Fluid overload
7%
Blood and lymphatic system disorders
7%
Pain in extremity
7%
Hypertension
6%
Abdominal pain
6%
Urinary tract infection
6%
Cough
6%
Hyperkalaemia
6%
Pruritus
6%
Investigations
6%
Dyspnoea
6%
Pneumonia
5%
Sepsis
5%
Non-cardiac chest pain
5%
Dizziness
4%
Acute respiratory failure
4%
Arteriovenous fistula thrombosis
4%
Arthralgia
4%
Fall
4%
Headache
4%
Anaemia
3%
Mental status changes
3%
Pulmonary oedema
3%
Cardiac failure congestive
3%
Cellulitis
2%
Angina pectoris
2%
Hip fracture
2%
Gastrointestinal haemorrhage
2%
Cardiac arrest
2%
Acute myocardial infarction
2%
Pleural effusion
2%
Cardio-respiratory arrest
1%
Hypoglycaemia
1%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1%
Immune system disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ferumoxytol
Iron Sucrose

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FerumoxytolExperimental Treatment1 Intervention
Group II: Iron sucroseActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferumoxytol
2011
Completed Phase 4
~4380

Find a Location

Who is running the clinical trial?

AMAG Pharmaceuticals, Inc.Lead Sponsor
43 Previous Clinical Trials
11,185 Total Patients Enrolled
21 Trials studying Anemia
6,865 Patients Enrolled for Anemia
~18 spots leftby Dec 2025
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