Ferumoxytol for Anemia of CKD Trial (FACT)- AMAG-FER-CKD-401
Research type
Research Study
Full title
Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-\nLabel, Multicenter Trial, with MRI Substudy, of Repeated Doses of\nFerumoxytol Compared with Iron Sucrose for the Treatment of\nIron Deficiency Anemia (IDA) in Chronic Kidney Disease (CKD)\nPatients on Hemodialysis
IRAS ID
122896
Contact name
Iain Macdougall
Contact email
Sponsor organisation
AMAG Pharmaceuticals, Inc.
Eudract number
2010-022133-28
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to see how well Feraheme® (ferumoxytol) injection (referred to as “ferumoxytol” throughout this form) works compared to iron sucrose (Venofer®) for treating IDA in patients with CKD when given potentially multiple times over a year and to see how safe it is and what side effects occur.\nAnaemia is known to impact the quality of life and may also be a health risk. Iron deficiency anaemia is very common in patients who have CKD and are undergoing dialysis. Iron therapy is the usual treatment for IDA. It is likely that most participants in the study have already been receiving iron therapy as part of their care. Iron therapy restores iron levels and helps the body maintain normal levels of hemoglobin (the part of the blood that carries oxygen). \nAt entry, all patients in this study will have IDA and CKD and be on hemodialysis. All patients in this study will receive a type of iron replacement therapy, either ferumoxytol or iron sucrose. Improvement in iron deficiency anaemia will be compared between the patients who receive ferumoxytol and the patients who receive iron sucrose. \nThe drugs used in this study, ferumoxytol and iron sucrose, are both intravenous (IV, injected into a vein) forms of iron treatment that are given to patients for the treatment of IDA in CKD
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0176
Date of REC Opinion
12 Aug 2013
REC opinion
Further Information Favourable Opinion