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)
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|ClinicalTrials.gov Identifier: NCT03619850|
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : July 15, 2020
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
To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease; Iron Deficiency Anemia||Drug: Ferumoxytol Drug: Iron sucrose||Phase 3|
This is a Phase 3, randomized, open-label, multicenter, study of the safety (compared to iron sucrose), efficacy, and PK/PD of ferumoxytol (7.0 mg Fe/kg x 2 [max 510 mg/dose]) in pediatric subjects with iron deficiency anemia (IDA) and CKD. There will be a total of approximately 125 subjects randomized to treatment in a 2:1 ratio to either ferumoxytol or iron sucrose.
Total subject participation in the study will be up to 7 weeks, which includes a 2-week Screening Period and a 5-week Treatment Period.
Subjects receive the following:
• Two IV infusions of ferumoxytol 7.0 mg Fe/kg (max 510 mg/dose), the first administered on Day 1 and the second 2-8 days later
• Iron sucrose (Venofer®): For Hemodialysis Dependent (HDD) patients: 2 mg Fe/kg, administered on consecutive dialysis sessions, for 10 doses (max 100mg/dose with a total max treatment course of 1000mg) For Non-hemodialysis Dependent (NDD) or Peritoneal Dialysis De pendent(PDD) patients: 4 mg Fe/kg, administered up to 3 times/week, for 5 doses (max 200mg/dose with a total max treatment course of 1000mg).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Randomized, Open-Label, Multicenter 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)|
|Actual Study Start Date :||August 13, 2018|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||January 31, 2022|
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.
Other Name: Feraheme
|Active Comparator: Iron sucrose||
Drug: 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).
Other Name: Venofer
- Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5 [ Time Frame: 35 days ]Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5
- Incidence of Treatment Emergent Adverse Events [ Time Frame: 49 days ]Incidence of Treatment Emergent Adverse Events
- Incidence of adverse events of special interest (AESI) [ Time Frame: 49 days ]Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)
- Area Under the Curve (AUC) [ Time Frame: 35 days ]Pharmacokinetic parameter: Area Under the Curve (AUC)
- Clearance [ Time Frame: 35 days ]Pharmacokinetic parameter: clearance
- Distribution and elimination half-lives [ Time Frame: 35 days ]Pharmacokinetic parameter: distribution and elimination half-lives
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619850
|Contact: Clinical Trial Interest||1-877-233-4781||AMAGCT@druginfo.com|