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

NCT01264679 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: AMAG-FER-CKD-253
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375) and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with ferumoxytol.

Conditions

Iron Deficiency Anemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean Change In Hemoglobin From Baseline To Week 5

  Mean changes in hemoglobin following the first course of ferumoxytol 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, and the AMAG-FER-CKD-253 study. 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 (2)

• Proportion Of Participants With An Increase In Hemoglobin From Baseline To Week 5 And To Week 7

  Baseline, Week 5 and Week 7

• Mean Change In TSAT From Baseline To Week 5 And To Week 7

  Baseline, Week 5 and Week 7

Study Arms (1)

Ferumoxytol

EXPERIMENTAL

When a participant has persistent or recurrent IDA (defined as hemoglobin \<12.0 grams \[g\]/deciliter \[dL\] and with either transferrin saturation \<40% or ferritin \<100 nanograms/milliliter), the participant will begin a 7-week treatment period. Participants will receive 2 IV injections of ferumoxytol 7.0 milligrams (mg) iron/kilogram (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.

Drug: Ferumoxytol

Interventions

Ferumoxytol DRUG

IV Ferumoxytol

Also known as: Feraheme

Ferumoxytol

Eligibility Criteria

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

You may qualify if:

• Participants who had completed participation in the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies within 4 weeks of screening
• Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study
• Participant and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study

You may not qualify if:

• Experienced a serious adverse event related to IV iron therapy in the combined AMAG-FER-CKD-251 and AMAG-FER- CKD-252 studies
• Hemoglobin level ≤7 g/dL

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead

Study Sites (1)

AMAG Pharmaceuticals, Inc.

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Renal Insufficiency, Chronic

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

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.

CTInterest@covispharma.com

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 22, 2010
• Study Start: December 27, 2011
• Primary Completion: April 24, 2015
• Study Completion: April 24, 2015
• Last Updated: April 28, 2022
• Results First Posted: November 6, 2017

Record last verified: 2022-03

Locations

US (1)