Open Label Extension Study for the Long-term Efficacy and Safety of FG-4592 in Dialysis and Non-dialysis Chronic Kidney Disease Patients
Open Label Extension Study for the Long-term Efficacy and Safety of FG-4592 in Dialysis and Non-dialysis Chronic Kidney Disease Patients
The purpose of this open-label extension study is to evaluate long-term efficacy and safety
 of FG-4592 in maintaining hemoglobin in dialysis and non-dialysis CKD patients who have
 completed the Treatment Period of an FG-4592 FibroGen-sponsored anemia study.
This is an open-label, long-term maintenance study of FG-4592 anemia therapy in dialysis and
 non-dialysis Chronic Kidney Disease patients who have completed the Treatment Period of an
 FG-4592 FibroGen-sponsored anemia Study. Subjects assigned to FG-4592 in the previous study
 will continue to receive the same FG-4592 dose and dosing frequency, unless a dose adjustment
 is required. An optional treatment group may allow subjects assigned to placebo in the
 previous study to start active FG-4592 study treatment.
Inclusion Criteria:

 1. Minimum age 18 years

 2. Completed the Treatment Period of an ongoing FG-4592 FibroGen-sponsored anemia study
 in the U.S.

 Exclusion Criteria

 1. Subjects assigned to epoetin alfa in a previous ongoing FG-4592 anemia study

 2. Pregnant or breastfeeding females

 3. Females of childbearing potential, unless using contraception as detailed in the
 protocol; male subjects with sexual partners of childbearing potential who are not on
 birth control unless the male subject agrees to use contraception

 4. Subjects who received FG-4592 in a previous study that did not demonstrate adequate
 hemoglobin response per the investigator's clinical judgment

 5. Any medical condition that in the opinion of the investigator may pose a safety risk
 to a subject in this study, or which may interfere with study participation