Trial record 10 of 237 for:
iron-deficiency anemia
Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease (FIRST)
This study has been completed.
Sponsor:
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01052779
First received: January 15, 2010
Last updated: April 3, 2013
Last verified: April 2013
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Purpose
The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in subjects with chronic kidney disease (CKD).
| Condition | Intervention | Phase |
|---|---|---|
|
Iron Deficiency Anemia Kidney Disease |
Drug: ferumoxytol Drug: iron sucrose |
Phase 2 |
| 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 Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease |
Resource links provided by NLM:
Further study details as provided by AMAG Pharmaceuticals, Inc.:
Primary Outcome Measures:
- To evaluate the safety of IV ferumoxytol compared to IV iron sucrose [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the efficacy of ferumoxytol as compared to iron sucrose by assessing changes in hemoglobin from Baseline to Week 5 [ Time Frame: 35 days ] [ Designated as safety issue: No ]
| Enrollment: | 162 |
| Study Start Date: | March 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Iron Sucrose Arm
Safety and efficacy of IV iron sucrose for the treatment of iron deficiency anemia (IDA) in subjects with chronic kidney disease (CKD)
|
Drug: iron sucrose
IV infusion of iron sucrose for a total cumulative dose of 1.0 g
|
|
Active Comparator: Ferumoxytol arm
Safety and efficacy of intravenous (IV) ferumoxytol for the treatment of iron deficiency anemia (IDA) in subjects with chronic kidney disease (CKD).
|
Drug: ferumoxytol
IV injection of ferumoxytol for a total cumulative dose of 1.02 g
Other Name: Feraheme
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Key Inclusion Criteria include:
- Males and females ≥18 years of age
- An eGFR <60 mL/min or a diagnosis of CKD (eg, nephropathy, nephritis)
- Hemoglobin <11.0 g/dL
- TSAT <30%
- Hemodialysis subjects on maintenance dialysis for at least three months prior to screening and currently receiving dialysis three times per week
- 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 the study
Exclusion Criteria:
Key Exclusion Criteria include:
- History of allergy to IV iron
- Allergy to 2 or more classes of drugs
- Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
- Hemoglobin ≤7.0 g/dL
- Received another investigational agent within 4 weeks prior to screening, or planned receipt of an investigational agent not specified by this protocol during the study period
- Known causes of anemia other than iron deficiency (eg, hemolysis, vitamin B12 or folate deficiency, etc)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052779
Locations
| United States, Massachusetts | |
| AMAG Pharmaceuticals, Inc. | |
| Lexington, Massachusetts, United States, 02421 | |
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
Investigators
| Study Director: | William Strauss, MD, FACC | AMAG Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | AMAG Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01052779 History of Changes |
| Other Study ID Numbers: | FER-CKD-201 |
| Study First Received: | January 15, 2010 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by AMAG Pharmaceuticals, Inc.:
|
Iron deficiency anemia chronic kidney disease Feraheme ferumoxytol |
iron sucrose iron deficiency anemia (IDA) chronic kidney disease (CKD) |
Additional relevant MeSH terms:
|
Anemia Anemia, Iron-Deficiency Anemia, Hypochromic Kidney Diseases Deficiency Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Hematologic Diseases Urologic Diseases Malnutrition Nutrition Disorders Iron Metabolism Disorders 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 16, 2013