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

This study has been terminated.
(Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 and is currently recruiting under study AMAG-FER-CKD-251.)
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01155388
First received: June 30, 2010
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Iron Deficiency Anemia
Nondialysis Dependent Chronic Kidney Disease
Drug: Ferumoxytol
Drug: Ferrous sulfate
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 Nondialysis-dependent 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)


Enrollment: 7
Study Start Date: April 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferumoxytol
Intravenous (IV) iron
Drug: Ferumoxytol
IV Ferumoxytol
Other Name: Feraheme
Active Comparator: Oral iron
Oral iron
Drug: Ferrous sulfate
Oral iron preparation

  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. Nondialysis dependent CKD, including kidney transplant recipients
  3. Has IDA defined as: a) hemoglobin <11.0 g/dL and b) TSAT <20%
  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. Allergy to two or more classes of drugs
  3. Female subjects who are pregnant, intend to become pregnant, are breastfeeding, within 3 months postpartum, or have a positive serum/urine pregnancy test
  4. Hemoglobin ≤7.0 g/dL
  5. Serum ferritin >600 ng/mL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155388

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

No publications provided

Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01155388     History of Changes
Other Study ID Numbers: AMAG-FER-CKD-252
Study First Received: June 30, 2010
Last Updated: December 12, 2013
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
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
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AMAG Pharmaceuticals, Inc.:
Iron deficiency anemia
Feraheme
ferumoxytol
CKD
pediatric
nondialysis-dependent
The treatment of iron deficiency anemia in pediatric subjects with nondialysis dependent 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
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014