| Eligibility |
Inclusion Criteria:
1. The subject voluntarily participated in this clinical trial and signed an informed
consent form;
2. 18-70 years old, weight 45~90kg, including cut-off value;
3. Hemodialysis (Hemodialysis, HD): Patients with end-stage renal disease who are on
stable dialysis receive 3 times a week hemodialysis for at least 3 months before
screening, and can receive 3 times a week hemodialysis at regular intervals during the
test. The duration of the subject's hemodialysis treatment must be 3-4.5 hours
(including the cut-off value); Peritoneal dialysis: For patients with end-stage renal
disease on stable dialysis, the subject must receive peritoneal dialysis for at least
3 months before screening;
4. Subjects stop EPO 14 days or 5 half-lives (whichever is the longest) before taking the
test drug for the first time;
5. Subjects have stable dialysis methods and dialysis prescriptions, and are expected to
have no major treatment changes or no drastic changes in their condition during the
clinical trial period;
6. During the screening period, the hemoglobin value obtained by the two tests of Visit 1
and Visit 2 must be > or = 8.0 g/dL and <11.0 g/dL, and the difference between the two
must be < or = 1.5 g/dL.
Exclusion Criteria:
1. Existence of past medical history or conditions that may cause anemia other than
nephropathy, including but not limited to blood system diseases, such as thalassemia,
aplastic anemia, hemolytic anemia, multiple myeloma, myelodysplastic syndrome, etc.;
Autoimmune diseases that may affect red blood cell production, such as systemic lupus
erythematosus, rheumatoid arthritis, etc.; Bleeding diseases, such as gastrointestinal
bleeding, obstetrics and gynecology bleeding diseases, etc.
2. During the study period, those who plan to change the dialysis method/mode or the flux
of the hemodialysis machine, such as changing from peritoneal dialysis to hemodialysis
3. Those who have any of the following heart/cerebrovascular diseases:
1. Acute coronary syndrome, stroke (except lacunar infarction) or thromboembolic
disease (such as deep vein thrombosis or pulmonary embolism) occurred within 6
months before screening;
2. Heart Function III of New York Society of Cardiology Or grade IV congestive heart
failure, or severe arrhythmia, including but not limited to ventricular
tachycardia, ventricular fibrillation, III degree atrioventricular block, etc.
4. Those who have any of the following medical or surgical history:
1. Those who plan to undergo major surgery 3 months before screening or during the
study period (except for hemodialysis access repair) or blood transfusion
therapy;
2. Have peritoneal dialysis related 3 months before screening Peritonitis, history
of infection or leakage of peritoneal tube tunnel;
3. history of malignant tumor within 5 years prior to screening (except for cured
skin basal cell carcinoma and cervical carcinoma in situ), or current assessment
of potential malignant tumor;
4. suffering Uncontrollable or symptomatic secondary hyperparathyroidism, plasma
iPTH>800pg/ml;
5. History of dysphagia or any gastrointestinal disease that affects drug
absorption, history of gastric/jejunum/colon resection; f ) Those who have a
serious infection and are receiving systemic antibiotic treatment;
g) Anyone who has participated or plans to participate in an organ transplant within 6
months; h) Have a history of chronic liver disease (such as: chronic infectious
hepatitis, chronic autoimmune liver disease, cirrhosis Or liver fibrosis); i) Patients
with a history of polycystic kidney disease.
5. Any of the following laboratory abnormalities during the screening period:
1. Folic acid <6.8nmol/L (3ng/ml) and/or VitB12<74pmol/L (100ng/ml);
2. Serum albumin <3 g/dL;
3. AIDS antibody , Treponema pallidum antibody, hepatitis B surface antigen or
hepatitis C antibody positive for any one;
4. ALT>3×ULN and/or AST>3×ULN, or total bilirubin>1.5× ULN;
6. Subjects received intravenous iron supplementation within 4 weeks before screening, or
used Chinese patent medicines, androgens and anabolic hormone drugs, hypoxia-inducible
factor prolyl hydroxylase for the treatment of anemia within 4 weeks before screening
Inhibitors (such as Roxastat capsules) and other drugs (except ESAs and their
derivatives, oral irons, stable oral irons can be taken within 4 weeks before the
screening, and in the screening period and after the start of the trial drug Continue
to take the fixed dose for 6 weeks.)
7. Subjects who are expected to take BCRP inhibitors, BCRP inducers, CYP2C8 inhibitors
and inducers within 14 days before taking the test drug (or 5 half-lives of the drug,
whichever is the longest) until the end of the drug;
8. Those who have a history of drug abuse or drug abuse within 6 months before screening;
9. The mean systolic blood pressure =180 mmHg and/or the diastolic blood pressure > or =
110 mmHg of two supine blood pressure measurements at least 1 hour apart during the
screening period;
10. People with a history of severe allergic disease or drug allergy, or those who are
allergic to test drugs or their excipients;
11. Those who drink more than 14 units per week in the 3 months before screening (1 unit
of alcohol ˜ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of
wine), or those who cannot abstain from alcohol during the hospitalization;
12. Those who smoked more than 10 cigarettes per day in the 3 months before screening, or
who could not stop using any tobacco products during the hospitalization;
13. Women who have a positive pregnancy test or are breastfeeding, or men and women who
refuse to take effective contraceptive measures within 4 weeks from the signing of the
informed consent form to the end of the last trial drug administration;
14. Participated in other clinical trials within 3 months before screening (Definition of
participation: accepted experimental drugs or instrument);
15. Subjects may not be able to complete all research visits or procedures required by the
research protocol, and/or fail to comply with all required research procedures;
16. The investigator believes that there are other factors that are not suitable for
participating in this trial;
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