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

NCT01155375 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: AMAG-FER-CKD-251
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Iron Deficiency Anemia

Keywords

Iron deficiency anemia; Feraheme; ferumoxytol; CKD; pediatric; dialysis-dependent; nondialysis-dependent

Outcome Measures

Primary Outcomes (1)

• Mean Change In Hemoglobin From Baseline To Week 5

  Mean changes in hemoglobin from Baseline to Week 5 were to be presented. Despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this primary outcome measure cannot be summarized nor can the statistical analysis, as described in the protocol, be provided in a way that will provide any significant data based upon the limited study datasets.

  Baseline, Week 5

Secondary Outcomes (1)

• Pharmacokinetics: Area Under The Curve Of Ferumoxytol

  Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose

Study Arms (2)

Ferumoxytol

EXPERIMENTAL

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.

Drug: Ferumoxytol

Oral Iron

ACTIVE COMPARATOR

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

Drug: Oral Iron

Interventions

Ferumoxytol DRUG

Experimental: Ferumoxytol

Ferumoxytol

Oral Iron DRUG

Active Comparator: Oral iron

Also known as: Ferrous fumarate

Oral Iron

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females 6 months to \<18 years of age
• CKD non-dialysis participants or dialysis-dependent participants who were on peritoneal dialysis or stable hemodialysis prior to Screening
• Had iron deficiency anemia defined as: a) hemoglobin level ≤12.0 grams/deciliter (g/dL) and b) with either transferrin saturation level ≤40% or ferritin level \<100 nanograms/milliliter (ng/mL)
• Female participants of childbearing potential who were sexually active must have been on an effective method of birth control for at least 1 month prior to Screening and agreed to remain on birth control until completion of participation in the study

You may not qualify if:

• History of allergy to either oral or IV iron
• Hemoglobin level ≤7.0 g/dL
• Serum ferritin level \>600 ng/mL
• Female participants who were pregnant or intended to become pregnant, or were breastfeeding, were within 3 months postpartum, or had a positive serum pregnancy test

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead

Study Sites (1)

AMAG Pharmaceuticals, Inc.

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ferrosoferric Oxide; Iron; ferrous fumarate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Metals, Heavy; Elements; Transition Elements; Metals

Limitations and Caveats

While sample data were collected, it was not run through any analysis to obtain the necessary outcome measure data. As such, summary of the data set is not possible.

Results Point of Contact

• Title: Medical Information
• Organization: AMAG Pharmaceuticals, Inc.

amag@druginfo.com

+1-877-411-2510

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: July 1, 2010
• Study Start: October 17, 2011
• Primary Completion: June 24, 2014
• Study Completion: June 24, 2014
• Last Updated: April 4, 2022
• Results First Posted: November 6, 2017

Record last verified: 2022-03

Locations

US (1)