A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Subjects With Chronic Kidney Disease
This study is currently recruiting participants.
Verified December 2012 by AMAG Pharmaceuticals, Inc.
Sponsor:
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01264679
First received: December 20, 2010
Last updated: December 17, 2012
Last verified: December 2012
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Purpose
To evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with ferumoxytol.
| Condition | Intervention | Phase |
|---|---|---|
|
The Episodic Treatment of Iron Deficiency Anemia in Pediatric Subjects With Chronic Kidney Disease |
Drug: Ferumoxytol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Extension Study of the Safety and Efficacy of Ferumoxytol for the Episodic 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:
- Assess the pattern of recurrence of IDA [ Designated as safety issue: No ]
| Estimated Enrollment: | 245 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ferumoxytol
Intravenous (IV) iron
|
Drug: Ferumoxytol
IV Ferumoxytol
Other Name: Feraheme
|
Eligibility| Ages Eligible for Study: | 6 Months to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria include:
- Subjects who have completed participation in study FER CKD 251 or FER CKD-252 within the past 4 weeks
- 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
- Subject and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study
Key Exclusion Criteria include:
- Experienced a serious adverse event (SAE) related to intravenous (IV) iron therapy in study FER CKD 251 or FER-CKD-252
- Hemoglobin ≤7 g/dL
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264679
Contacts
| Contact: William Strauss, MD | 617-498-2893 | pedstudyinfo@amagpharma.com |
Locations
| United States, Massachusetts | |
| AMAG Pharmaceuticals, Inc. | Recruiting |
| Lexington, Massachusetts, United States, 02421 | |
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
More Information
No publications provided
| Responsible Party: | AMAG Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01264679 History of Changes |
| Other Study ID Numbers: | AMAG-FER-CKD-253 |
| Study First Received: | December 20, 2010 |
| Last Updated: | December 17, 2012 |
| 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 Lithuania: State Medicine Control Agency - 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, pediatric nondialysis-dependent |
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 Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013