This study is a single-arm, open-label, multicenter and prospective study, which is conducted to evaluate the effect of Roxadustat on anemia in subjects with DKD (stage III-IV).
This study will consist of three study periods as follows: Screening Period: 2 weeks Treatment Period: 24weeks Follow-up Period: 4 weeks
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
124
The starting dose of Roxadustat will be defined as per the China Package Insert. The recommended starting dose of roxadustat will depend on the body weight of the patient (based on patient's empty weight prior to instillation of dialysate): 70 mg (40 to \< 60 kg) tiw or 100 mg (≥ 60 kg) tiw. The frequency of hemoglobin concentration test should be ≥ once every 4 weeks. The dose will be adjusted according to the following table every 4 weeks to achieve and/or maintain hemoglobin within the target range (10.0-12.0 g/dl).
Second Xiangya Hospital, Central South University
Changsha, China
Hb level
Change in average Hb level from baseline to week 24.
Time frame: at week 0,2,4,8,12,16,20,24
serum transferrin level
Change in serum transferrin level from baseline to week 24
Time frame: test at week 0,12 and 24
serum ferritin level
Change in serum ferritin level from baseline to week 24
Time frame: test at week 0,12 and 24
serum TSAT level
Change in serum TSAT level from baseline to week 24
Time frame: test at week 0,12 and 24
serum iron level
Change in serum iron level from baseline to week 24
Time frame: test at week 0,12 and 24
FPG and PPG
Change in FPG and PPG levels from baseline to week 24
Time frame: test at week 0,12 and 24
HbA1C level
Change in HbA1C level from baseline to week 24
Time frame: test at week 0,12 and 24
Triglycerides, Cholesterol, HDL, LDL levels
Change in triglycerides, cholesterol, HDL, and LDL levels from baseline to week 24
Time frame: test at week 0,12 and 24
apolipoprotein level
Change in apolipoprotein level from baseline to week 24
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Time frame: test at week 0,12 and 24
Physical parameters
SF-36 summary scores (PCS and MCS), physical functioning and vitality
Time frame: test at week 0,12 and 24