A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
Who is this study for? Child patients with Iron Deficiency Anemia
What treatments are being studied? Ferumoxytol
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• Male or female 2 years to \<18 years of age at time of consent
• Has IDA defined as:
‣ Hemoglobin (Hgb) \<11.0 g/dL AND
⁃ Any one or more of the following:
• Transferrin saturation (TSAT) \<20%
∙ ferritin \<100 ng/mL
• Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
Locations
United States
Arkansas
Arkansas Children's Hospital
NOT_YET_RECRUITING
Little Rock
Florida
University of Florida
NOT_YET_RECRUITING
Gainesville
Biomedical Research LLC
RECRUITING
Miami
Optimus U Corporation
RECRUITING
Miami
Georgia
Gwinnett Research Institute
NOT_YET_RECRUITING
Buford
Texas
Sun Research Institute
RECRUITING
San Antonio
Other Locations
Lithuania
JSC Saules seimos medicinos centras
NOT_YET_RECRUITING
Kaunas
Klaipeda Children's Hospital
NOT_YET_RECRUITING
Klaipėda
Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos
NOT_YET_RECRUITING
Vilnius
Poland
Osrodek Badan Klinicznych In Vivo sp. z o.o.
NOT_YET_RECRUITING
Bydgoszcz
Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek
NOT_YET_RECRUITING
Dębica
Pro Familia Altera Sp. z o.o.
NOT_YET_RECRUITING
Katowice
Korczowski Bartosz, Gabinet Lekarski
NOT_YET_RECRUITING
Rzeszów
Centrum Zdrowia MDM
NOT_YET_RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
NOT_YET_RECRUITING
Wroclaw
Contact Information
Primary
Clinical Trial Interest
CTInterest@covispharma.com
1-877-374 -4177
Time Frame
Start Date:2019-09-18
Estimated Completion Date:2025-10
Participants
Target number of participants:75
Treatments
Experimental: Ferumoxytol
Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution.
Active_comparator: Iron sucrose
Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL)
Who is this study for: Children 0 to <18 years of age with iron deficiency anemia due to NDD-CKD or with iron deficiency anemia who are intolerant or unresponsive to oral iron