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Compares treatment options for Chronic Kidney Disease; Iron Deficiency Anemia
Official title 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 ID: NCT03619850
What this study is testing
What is Ferumoxytol?
Ferumoxytol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic kidney disease; iron deficiency anemia.
Also referred to as Feraheme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Primary Objectives: To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA Secondary Objective: To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Male or female 2 years to \<18 years of age at time of consent
- Has IDA defined as: a) hemoglobin \<12.0 g/dL and b) with either transferrin saturation (TSAT) \<40% or ferritin \<100 ng/mL; or considered to be at...
- Has Chronic Kidney Disease defined as one of the following:
- on chronic hemodialysis;
- receiving chronic peritoneal dialysis;
You likely can't join if
- Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose
- History of allergy to intravenous (IV) iron
- History of multiple drug allergies (\>2)
- Low systolic blood pressure (Age 1-9 years \<70 + [age in years x 2] mmHg, Age 10-17 years \<90 mmHg)
- Hemoglobin ≤7.0 g/dL
- Serum ferritin level \>600 ng/mL
See the full eligibility criteria
- Male or female 2 years to \<18 years of age at time of consent
- Has IDA defined as: a) hemoglobin \<12.0 g/dL and b) with either transferrin saturation (TSAT) \<40% or ferritin \<100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT\<20% with falling hemoglobin...
- Has Chronic Kidney Disease defined as one of the following:
- on chronic hemodialysis;
- receiving chronic peritoneal dialysis;
- estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m2;
- has evidence of structural and/or functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for \> 3 months.
- For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
- All people (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until...
- Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose
- History of allergy to intravenous (IV) iron
- History of multiple drug allergies (\>2)
- Low systolic blood pressure (Age 1-9 years \<70 + [age in years x 2] mmHg, Age 10-17 years \<90 mmHg)
- Hemoglobin ≤7.0 g/dL
- Serum ferritin level \>600 ng/mL
The study team makes the final eligibility decision.
Where it's taking place
- Hollywood, Florida, United States
- Detroit, Michigan, United States
- Kansas City, Missouri, United States
- Lake Success, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Akron, Ohio, United States
- Morgantown, West Virginia, United States
- Budapest, Hungary
- Szeged, Hungary
- Kaunas, Lithuania
- Klaipėda, Lithuania
- Vilnius, Lithuania
- Cuernavaca, Mexico
- Guadalajara, Mexico
- Mexico City, Mexico
- Bialystok, Poland
- Krakow, Poland
- Lodz, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hollywood, Florida, United States; Detroit, Michigan, United States; Kansas City, Missouri, United States; Lake Success, New York, United States; New York, New York, United States; The Bronx, New York, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.