anemia in patients with chronic kidney disease receiving hemodialysis or peritoneal dialysis
Conditions
Interventions
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide a signed and dated written informed consent (ICF); 2. aged >= 18 years old; 3. ESRD patient received peritoneal dialysis more than 4 weeks and abdominal catheterization available before the first visit; Or the patient received hemodialysis for more than 1 year before the first visit, the arteriovenous fistula was normally available, and the current hemodialysis was performed three times a week. 4. the patient did not receive ESA treatment after starting dialysis: The average Hb level of the last two (at least 7 days before the start of the study treatment and during the screening period) was =7 g/dL and =LLN, serum vitamin B12 level >=LLN; 7. alanine transaminase or aspartate aminotransferase (AST) <=3 ULN, total bilirubin (TBL) <=2 ULN; 8. The expected survival time is more than 1 year; 9. weight is 45 to 160 kg (specified 'dry' weight).
Exclusion criteria
Exclusion criteria: 1. According to the judgment of the researchers, patients with peritoneal dialysis may not continue to receive peritoneal dialysis during the study period, or may need to be transferred to hemodialysis; 2. a history of severe, chronic, end-stage or uncontrolled autoimmune liver disease, Child Pugh score was grade C, or with active hepatitis; 3. preparing for pregnancy or pregnancy or lactation; 4. having anemia caused by any other disease other than CKD, such as thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, tumor-related anemia, chemotherapy-related anemia, and myelodysplastic syndrome; 5. malignant tumor, such as prostate cancer, breast cancer, renal cell cancer or any other malignant tumor history or diagnosed (excluding confirmed cure or remission of >=5 years; Surgically removed basal or squamous cell skin cancer, carcinoma in situ of the cervix, or removed colon polyps; 6. The doctor considered that the patient suffers from a serious illness, including but not limited to: (1) Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk of retinal vein thrombosis); (2) In patients with poorly controlled hypertension before the study, systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg maintained with 3 or more antihypertensive drugs; uncontrolled hypertension after dialysis and so on; (3) A history of type 1 diabetes or a current diagnosis of the disease; (4) autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, ankylitis or psoriatic arthritis; (5) Known hemochromatosis, hemochromatosis, or hypercoagulability; (6) Any existing adverse condition of active blood loss; (7) congestive heart failure (New York heart function grade III or IV) at enrollment; (8) the presence of acute coronary syndrome, stroke, seizure, or thromboembolic events (e.g., deep vein thrombosis or pulmonary embolism) in the 12 weeks prior to treatment initiation; (9) active or significant severe infection; 7. Any red blood cell infusion during the screening period; 8. Any previous organ transplant or scheduled date for organ transplant; 9. Previous/accompanying clinical research experience; 10. The patient is known to be allergic to the active substance (Roxadustat) or any excipient of the product; 11. Other conditions considered inappropriate by other clinicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Hb level; | — |
Secondary
| Measure | Time frame |
|---|---|
| the proportion of patients with Hb >=10 g/dL;the change of Hb;the dose of Roxadustat used;the proportion of patients with different Hb levels;Serum iron;Cholesterol;blood pressure;The proportion of patients with low response to ESA; | — |
Countries
China
Contacts
Public ContactFu Ping
West China Hospital, Sichuan University
Outcome results
None listed