Dolomites
Research type
Research Study
Full title
Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
IRAS ID
131080
Contact name
Iain Macdougall
Contact email
Sponsor organisation
Astellas Pharma Europe B.V.
Eudract number
2013-000951-42
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Anemia is a common complication in patients with CKD. There is currently an unmet medical need for an oral treatment that will correct anemia in CKD patients to a target Hb level that is safe and well tolerated. FG-4592 is an oral medication that could potentially deliver effective treatment for CKD-related anemia with less need for iron supplementation and without producing supraphysiologic levels of circulating EPO.
The primary objective of this study is to evaluate the efficacy of FG-4592 compared to darbepoetin alfa in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) subjects.
The secondary objectives of this study are to:
Evaluate the safety of FG-4592 compared to darbepoetin alfa in the treatment of anemia in non-dialysis CKD subjects.
Evaluate the health-related quality of life (HRQoL) benefit of FG-4592 compared to
darbepoetin alfa in the treatment of anemia in non-dialysis CKD subjects.REC name
London - Fulham Research Ethics Committee
REC reference
13/LO/1517
Date of REC Opinion
4 Dec 2013
REC opinion
Further Information Favourable Opinion