chronic kidney disease undergoing long-term hemodialysis
Conditions
Interventions
single arm:Roxadustat
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18 to 75 years. 2. Subject had voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC), after the nature of the study had been explained and the subject had the opportunity to ask questions. 3. CKD with end-stage renal disease (ESRD) on adequate hemodialysis (HD) for a minimum of 16 weeks prior to Day 1. The vascular access must have been set up via native arteriovenous (AV) fistula or graft, or permanent, tunneled catheter. 4. Subjects must meet the chronic rhEPO hyporesponsiveness definition prior to Day 1. 5. The mean of the 2 most recent central laboratory hemoglobin (hemoglobin) values during the Screening Period, obtained at least 6 days apart, must have been 60-120 g/L, noninclusive. 6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.5 * upper limit of normal (ULN), and normal total bilirubin at the screening visit except for subjects with Gilberts syndrome. 7. Body weight: 40 to 100 kg inclusive. 8. Subjects must have agreed to not start taking any new Traditional Chinese Medicine (TCM) for anemia and not to change dose, schedule, or brand of any prescreening TCM for anemia from the beginning of the Screening Period through the end of the Follow-up Period.
Exclusion criteria
Exclusion criteria: 1. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab). 2. Chronic liver disease. 3. New York Heart Association Class III or IV congestive heart failure. 4. Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (e.g., deep venous thrombosis or pulmonary embolism) within 52 weeks prior to Day 1. 5.Uncontrolled hypertension in the opinion of the investigator (e.g., that required change in anti- hypertensive medication within 2 weeks prior to randomization). 6. Diagnosed or suspected renal cell carcinoma (e.g., complex kidney cyst of Bosniak Category II or higher) as shown on renal ultrasound during the Screening Period. 7. History of malignancy except for the following: cancers determined to be cured or in remission for >=5 years, curatively resected basal cell or squamous cell skin cancers, or in situ cancer at any site. 8. Chronic inflammatory disease other than glomerulonephritis that could have impacted erythropoiesis (e.g., systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease). 9. Clinically significant gastrointestinal bleeding. 10. Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis,hemochromatosis, known coagulation disorder, or hypercoagulable condition. 11. Any prior functioning organ transplant or a scheduled organ transplantation, or anephric. 12. Anticipated elective surgery that could have led to significant blood loss during the study period. 13. Anticipated use of dapsone or acetaminophen (paracetamol) >2.0 g/day, or >500 mg per dose repeated every 6 hours for more than 3 day. 14. Serum albumin 3 alcoholic beverages per day. 19. Prior treatment with Roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). 20. Use of an investigational medication or treatment, participation in an investigational interventional study, or carryover effect of an investigational treatment expected during the study. 21. Women who are pregnant or breastfeeding. 22. Women of childbearing potential and men with sexual partners of childbearing potential who are not using adequate contraception. 23. Any medical condition that, in the opinion of the investigator, posed a safety risk to a subject in this study, confounded efficacy or safety assessments, or interfered with study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Iron metabolism markers;blood pressure;life quality;lipid metabolism markers; | — |
Countries
China
Contacts
Public ContactRong Wang
Shandong Provincial Hospital
Outcome results
None listed