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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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 49 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5

Secondary outcome measures

Incidence of Treatment Emergent Adverse Events

Incidence of adverse events of special interest (AESI)

Other outcome measures

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

Hypotension

Psychiatric disorders

Vomiting

Muscle spasms

Pyrexia

Arteriovenous fistula site complication

Upper respiratory tract infection

Blood and lymphatic system disorders

Fluid overload

Pain in extremity

Hypertension

Urinary tract infection

Hyperkalaemia

Investigations

Pruritus

Abdominal pain

Cough

Dyspnoea

Pneumonia

Sepsis

Non-cardiac chest pain

Dizziness

Arteriovenous fistula thrombosis

Fall

Acute respiratory failure

Arthralgia

Headache

Anaemia

Mental status changes

Pulmonary oedema

Cardiac failure congestive

Cellulitis

Angina pectoris

Gastrointestinal haemorrhage

Hip fracture

Cardiac arrest

Acute myocardial infarction

Pleural effusion

Cardio-respiratory arrest

Hypoglycaemia

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Immune system disorders

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AMAG Pharmaceuticals, Inc.Lead Sponsor

43 Previous Clinical Trials

11,237 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why is Ferumoxytol often given to patients?

"Oral cavity conditions are commonly treated with Ferumoxytol. This medication can also help patients who need iron, dietary supplementation, and suffer from iron deficiency anemia."

Answered by AI

Are investigators still recruiting patients for this research study?

"The information available on clinicaltrials.gov suggests that this study is still trying to enroll patients. The listing for the trial was first posted on August 13th, 2018 and last updated on June 7th, 2022."

Answered by AI

How many people total have signed up to be a part of this clinical research?

"In order to run this clinical trial, we need 129 patients that meet the pre-specified inclusion criteria. Patients can travel to one of our many locations, such as Akron Nephrology Associates, Inc. in Akron, Ohio and Children's Mercy Hospital in Kansas City, Missouri."

Answered by AI

Are minors allowed to participate in this research project?

"Children aged 2 to 17 can enroll in this clinical trial. Out of the 826 total trials, this is one of 154 that specifically includes paediatric patients."

Answered by AI

Is this the first time Ferumoxytol has been trialed?

"The first clinical trial for ferumoxytol was at Stanford University Cancer Institute in 2012. As of now, there have been a total of 192 completed clinical trials worldwide. Currently, 33 of these studies are still active; many of them taking place in Akron, Ohio."

Answered by AI

If I join this study, what medical procedures will I undergo?

"Kids aged 2-17 who suffer from chronic kidney disease can be enrolled in this study, of which there are 129 open slots for participants."

Answered by AI

Has Ferumoxytol been cleared by the FDA?

"Ferumoxytol has received a 3 for safety. This is due to the fact that it is in Phase 3 clinical trials, which suggests that not only is there some data supporting its efficacy, but also multiple rounds of data indicating that it is safe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2018. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03619850.

All > Chronic Kidney Disease