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Iron Supplement

Ferumoxytol for Chronic Kidney Disease

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

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
  • Chronic Kidney Disease, Iron Deficiency 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

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
~18 spots leftby Sep 2025
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