Clinical trial NCT01155388: A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease
Official title: A Randomized, Open-Label, Active-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Ferumoxytol Compared With Oral Iron for the Treatment of Iron Deficiency Anemia in Pediatric Subjects With Nondialysis-dependent Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Nondialysis-dependent Chronic Kidney Disease
Keywords: Iron deficiency anemia
Feraheme
ferumoxytol
CKD
pediatric
nondialysis-dependent
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).

Detailed description: Study AMAG-FER-CKD-252 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with nondialysis-dependent CKD. Study AMAG-FER-CKD-251 (NCT01155375) was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with dialysis-dependent CKD. Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251. The enrollment number (n=14) includes the number of participants for both AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, combined.

Participants were enrolled by age cohorts in a stepwise manner following a safety review by the Data Safety Monitoring Board of 1 age cohort prior to enrollment of a subsequent age cohort, with progression from oldest to youngest. Randomization was stratified by the following age cohorts: 12 to \<18 years, 6 to \<12 years, 2 to \<6 years, and 6 months to \<2 years.

Eligibility criteria: Key Inclusion Criteria for this study include:

1. Males or females 6 months to \<18 years of age
2. Nondialysis dependent CKD, including kidney transplant recipients
3. Has iron deficiency anemia defined as: a) hemoglobin level \<11.0 grams (g)/deciliter (dL) and b) transferrin saturation level \<20%
4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria for this study include:

1. History of allergy to either oral or IV iron
2. Allergy to two or more classes of drugs
3. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 3 months postpartum, or have a positive serum/urine pregnancy test
4. Hemoglobin level ≤7.0 g/dL
5. Serum ferritin level \>600 nanograms/milliliter

Primary outcomes:
measure: Mean Change In Hemoglobin From Baseline To Week 5
timeFrame: Baseline, Week 5
Secondary outcomes:
measure: Pharmacokinetics: Area Under The Curve Of Ferumoxytol
timeFrame: Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose
Other outcomes:
Locations:
city: Waltham
country: United States
facility: AMAG Pharmaceuticals, Inc.
state: Massachusetts
Study officials:
References: