Renal anemia
Conditions
Interventions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Able to provide informed consent, complete all study assessments, and have a complete medical history; (2) Age 18–80 years (including boundary values), no gender restrictions; (3) Weight >=45 kg; (4) Diagnosed with chronic renal failure, having received at least 12 weeks of stable hemodialysis treatment prior to enrollment, and with no plans to change the dialysis method during the observation period; (5) Have a record of anemia medication use within the 12 weeks prior to enrollment (including type, dose, and frequency of medication); (6) Have received short-acting rHuEPO therapy within the 12 weeks prior to enrollment, with a maximum weekly dose =8 g/dL and <11 g/dL within the 4 weeks prior to enrollment; (9) Study participants who, based on the physician's medical judgment and the patient's own wishes, are.
Exclusion criteria
Exclusion criteria: (1) Known to have malignant tumors, autoimmune diseases, hematological disorders (including congenital and acquired conditions such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndrome, hemolytic anemia, and coagulation disorders), or other causes of anemia unrelated to CKD (such as gastrointestinal bleeding or hookworm disease); (2) Received red blood cell or whole blood transfusion therapy within 12 weeks prior to enrollment; (3) Received prolyl hydroxylase inhibitors (HIF-PHIs) or intermediate- or long-acting erythropoietin (EPO) agents (e.g., darbepoetin alfa, methoxy polyethylene glycol-epoetin beta, etc.) within 12 weeks prior to enrollment; (4) Known allergy to iron supplements or polyethylene glycol molecules; (5) Uncontrolled blood pressure, as determined by the investigator to be unsuitable for participation in this study (uncontrolled hypertension is defined as: two or more blood pressure measurements during the screening period with systolic blood pressure >180 mmHg, or diastolic blood pressure >110 mmHg, or blood pressure values below the above standards but the investigator deems it necessary to adjust antihypertensive medications); ; (6) Plans to undergo kidney transplantation surgery or has a kidney donor during the study observation period, or plans to undergo elective surgery during the study observation period; (7) Pregnant or breastfeeding women, or those with plans to become pregnant during the study period; (8) Study participants deemed by the investigator to have any other factors that make them unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of study participants with Hb response at week 12.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hb level at week 0, 4, 8, 12, 16 ;Mean change in Hb level at week 4,8,12,16 from baseline.;Hb variability;The proportion of participants with Hb levels of 10.0–12.0 g/dl, 11.0–13.0 g/dl, =10.0 g/dl, and >13.0 g/dl at each follow-up site; | — |
Countries
China
Contacts
Public ContactFu Ping
West China Hospital of Sichuan University
Outcome results
None listed