A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease
| Status: | Terminated |
|---|---|
| Conditions: | Iron Deficiency Anemia, Renal Impairment / Chronic Kidney Disease, Anemia |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 11/8/2017 |
| Start Date: | October 17, 2011 |
| End Date: | June 24, 2014 |
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 evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral
iron for the treatment of pediatric participants with chronic kidney disease (CKD).
iron for the treatment of pediatric participants with chronic kidney disease (CKD).
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.
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.
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
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