A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease

NCT ID: NCT01155388

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-17
• Study Completion Date: 2014-06-24

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.

Conditions

Iron Deficiency Anemia; Nondialysis-dependent Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferumoxytol

Participants will receive 1 of the following 2 ferumoxytol dose regimens:

• Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.
• Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9.

Group Type: EXPERIMENTAL

Ferumoxytol

Intervention Type: DRUG

Experimental: Ferumoxytol

Oral Iron

Participants will receive oral iron: 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.

Group Type: ACTIVE_COMPARATOR

Oral Iron

Intervention Type: DRUG

Active Comparator: Oral iron

Interventions

Ferumoxytol

Experimental: Ferumoxytol

Intervention Type: DRUG

Oral Iron

Active Comparator: Oral iron

Intervention Type: DRUG

Other Intervention Names

Ferrous fumarate

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AMAG Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AMAG Pharmaceuticals, Inc.

Waltham, Massachusetts, United States

Countries

United States

Other Identifiers

AMAG-FER-CKD-252

Identifier Type: -

Identifier Source: org_study_id