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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by AMAG Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01155375
First received: June 28, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

To evaluate the efficacy and safety of IV ferumoxytol compared with oral iron for the treatment of pediatric subjects with chronic kidney disease.


Condition Intervention Phase
Iron Deficiency Anemia
Drug: Ferumoxytol
Drug: Ferrous fumarate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by AMAG Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Hemoglobin changes [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic (PK) analysis [ Designated as safety issue: No ]
    • Maximum concentration (Cmax)
    • Area under the curve (AUC)
    • Half-life (t1/2)


Estimated Enrollment: 288
Study Start Date: April 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral iron
Oral iron
Drug: Ferrous fumarate
oral iron preparation
Experimental: Ferumoxytol
Intravenous (IV) iron
Drug: Ferumoxytol
IV Ferumoxytol

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria include:

  1. Males or females 6 months to <18 years of age
  2. CKD non-dialysis subjects or dialysis dependent subjects who are on peritoneal dialysis or stable hemodialysis prior to screening
  3. Has IDA defined as: a) hemoglobin ≤12.0 g/dL and b) with either TSAT ≤40% or ferritin <100 ng/mL
  4. Female subjects 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 include:

  1. History of allergy to either oral or intravenous (IV) iron
  2. Hemoglobin ≤7.0 g/dL
  3. Serum ferritin >600 ng/mL
  4. Female subjects who are pregnant or intend to become pregnant, or are breastfeeding, are within 3 months postpartum, or have a positive serum pregnancy test
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155375

Contacts
Contact: William Strauss, MD 617-498-2893 pedstudyinfo@amagpharma.com

Locations
United States, Massachusetts
AMAG Pharmaceuticals, Inc. Recruiting
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01155375     History of Changes
Other Study ID Numbers: AMAG-FER-CKD-251
Study First Received: June 28, 2010
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Mexico: Ministry of Health
Poland: Ministry of Health
Peru: Ministry of Health
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AMAG Pharmaceuticals, Inc.:
Iron deficiency anemia
Feraheme
ferumoxytol
CKD
pediatric
dialysis-dependent
non-dialysis dependent
The treatment of iron deficiency anemia in pediatric subjects with chronic kidney disease.

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Deficiency Diseases
Anemia, Iron-Deficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Ferumoxytol
Ferrous fumarate
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014