A Phase IV Trial of Repeated Doses of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease on Hemodialysis (FACT)
This study is not yet open for participant recruitment.
Verified February 2013 by AMAG Pharmaceuticals, Inc.
Sponsor:
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01227616
First received: October 22, 2010
Last updated: February 11, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.
| Condition | Intervention | Phase |
|---|---|---|
|
The Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease |
Drug: Ferumoxytol Drug: Iron Sucrose |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, With MRI Substudy, of Repeated Doses of Ferumoxytol Compared With Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA) in Chronic Kidney Disease (CKD) Patients on Hemodialysis |
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:
- Changes in TSAT [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | January 2015 (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: IV Iron Sucrose
Intravenous (IV) iron
|
Drug: Iron Sucrose
IV Iron Sucrose
Other Name: Venofer
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria include:
- Males and females ≥18 years of age
- Diagnosis of CKD
- Subjects on dialysis must have been on dialysis for at least 3 months prior to screening
- 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:
- History of allergy to either oral or IV iron
- Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
- Parenteral iron therapy within 30 days prior to screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to screening or planned during the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227616
Contacts
| Contact: William Strauss, MD | 617-498-7696 | factstudyinfo@amagpharma.com |
Locations
| United States, Massachusetts | |
| AMAG Pharmaceuticals, Inc. | Not yet 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: | NCT01227616 History of Changes |
| Other Study ID Numbers: | AMAG-FER-CKD-401 |
| Study First Received: | October 22, 2010 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by AMAG Pharmaceuticals, Inc.:
|
Iron deficiency anemia (IDA), Feraheme, ferumoxytol, chronic kidney disease (CKD), hemodialysis, magnetic resonance imaging (MRI) |
Additional relevant MeSH terms:
|
Anemia, Iron-Deficiency Iron Metabolism Disorders Anemia Kidney Diseases Deficiency Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Hematologic Diseases Urologic Diseases Malnutrition Nutrition Disorders Anemia, Hypochromic Metabolic Diseases |
Renal Insufficiency Ferric oxide, saccharated Ferumoxytol Ferric Compounds Iron Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013