The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of anemia in non-dialysis chronic kidney disease patients.
Dose ranging study with two consecutive dose escalation cohorts. The study objective is to demonstrate that FG-4592 is effective in the correction of anemia in chronic kidney disease patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Sichuan Provincial People's Hospital
Chengdu, China
Maximum change in hemoglobin by Week 9 from baseline
Time frame: Week 9
Proportion of subjects achieving a target Hb level ≥11 g/dL by Weeks 5,6,7,8 and 9.
Time frame: Week 9
Proportion of subjects with a Hb increase from baseline ≥1.0 g/dL.
Time frame: Week 9
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West China Hospital
Chengdu, China
First affiliated hospital of Dalian medical university
Dalian, China
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
Zhejiang University No 1. Hospital
Hangzhou, China
Chang Zheng Hospital
Shanghai, China
Huashan Hospital
Shanghai, China
Renji Hospital
Shanghai, China
...and 3 more locations