A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferum… (NCT03619850) | Clinical Trial Compass
RecruitingPhase 3
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)
United States129 participantsStarted 2018-08-13
Plain-language summary
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.
Who can participate
Age range2 Years – 17 Years
SexALL
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Inclusion 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 during the preceding 2 months and a history of hemoglobin \<12 g/dL
✓. 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
Exclusion criteria
✕. Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose
✕. History of allergy to intravenous (IV) iron
✕. History of multiple drug allergies (\>2)
✕
What they're measuring
1
Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5