A Study of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients Not Receiving Dialysis

There is a screening period of up to 6 weeks, a variable treatment period for individual
subjects. In order to complete the treatment period simultaneously for all study subjects,
the minimum treatment duration may be less than 52 weeks, with a maximum treatment duration
of up to 3 years after the last subject is randomized, and a post-treatment follow-up period
of 4 weeks. Subjects were randomized in a 2:1 ratio to receive either roxadustat (FG-4592) or
placebo in a double-blind manner.

Inclusion Criteria:

- Chronic kidney disease, Stage 3, 4, or 5, not receiving dialysis

- Anemia qualified by measurements of hemoglobin values during screening

- Additional blood work must be in a safe range for study entry

- Body weight 45 to 160 kg

- Willingness to use contraception if of child-bearing potential

Exclusion Criteria:

- Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to
study participation

- More than one dose of intravenous iron within 12 weeks prior to study participation

- Blood transfusion within 8 weeks prior to study participation

- Active infection

- Chronic liver disease

- Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot

- Uncontrolled blood pressure within 2 weeks prior to study participation

- Renal cell carcinoma

- History of malignancy, including multiple myeloma or other myelodysplastic syndrome

- Chronic inflammatory disease that could impact red blood cell production

- Any prior organ transplant, or a scheduled organ transplantation

- Anticipated elective surgery that is expected to lead to significant blood loss, or
anticipated elective heart procedure

- Gastrointestinal bleeding

- Any prior treatment with FG-4592 or a HIF-PHI

- Recent use of an investigational drug or treatment, or participation in an
investigational study