FG-4592 in the Treatment of Anemia in Chronic Kidney Disease Patients
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients not on Dialysis
IRAS ID
123322
Contact name
Ashraf Mikhail
Contact email
Sponsor organisation
Astellas Pharma Europe B.V.
Eudract number
2012-005180-27
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
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 in the treatment of
anemia in non-dialysis CKD subjects.
The secondary objectives in this study are to:
● Evaluate the safety of FG-4592 in the treatment of anemia in non-dialysis CKD subjects.
● Evaluate HRQoL benefit of FG-4592 treatment in subjects with CKD anemia.
● Evaluate the need for rescue therapy: (RBC transfusion, or ESA, or IV iron.
This is a phase 3, multi-center, randomized, double-blind, placebo controlled study in anemic
subjects with Stage 3, 4 or 5 CKD who are not on dialysis. This study is planned to recruit
subjects from approximately 125 study centers in Europe, Russia Turkey and Israel.
The study population consists of subjects with CKD stages 3, 4, and 5 who are anemic and do not need dialysis.Subjects will take FG-4592 or placebo orally. The study will consist of three study periods as follows:
● Screening period: up to 6 weeks.
● Treatment period: minimum 52 weeks up to a maximum of 104 weeks or until the last subject randomized to treatment has completed 40 weeks of treatment (or at the forecasted week 40 date if this subject discontinues treatment early).
● Post-Treatment Follow-Up period: 4 weeks.REC name
London - City & East Research Ethics Committee
REC reference
13/LO/0549
Date of REC Opinion
24 Jun 2013
REC opinion
Further Information Favourable Opinion