Status:
COMPLETED
Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis
Lead Sponsor:
AMAG Pharmaceuticals, Inc.
Conditions:
Iron Deficiency Anemia Treatment
Chronic Kidney Disease(CKD)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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-dependen...
Detailed Description
This was a Phase IV, randomized, open-label, active-controlled, multicenter clinical trial designed to evaluate the safety, efficacy, and frequency of use of ferumoxytol compared to iron sucrose for t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT01227616
Start Date
August 1 2013
End Date
February 1 2017
Last Update
April 21 2022
Active Locations (43)
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1
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Pine Bluff, Arkansas, United States, 71603
2
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Azusa, California, United States, 91702
3
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Beverly Hills, California, United States, 90211
4
For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Los Angeles, California, United States, 90022