Renal anemia is one of the most common complications in patients undergoing peritoneal dialysis (PD), which seriously affects their quality of life and survival time [1, 2]. In maintenance peritoneal dialysis patients, the decline in renal function leads to insufficient secretion of endogenous erythropoietin. Meanwhile, factors such as shortened red blood cell lifespan, altered iron homeostasis, a
Conditions
Interventions
Experimental group:Pemossapide is administered by subcutaneous injection once every 4 weeks. The initial dosage is 0.04 mg/kg, and it is administered subcutaneously.
Control group:Erythropoietin Injection (rhuEPO) subcutaneous injection
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Provide an informed consent form before any study of a specific procedure; 2. The age at the screening visit should be >= 18 years old; 3. Have received or started peritoneal dialysis treatment; 4. During the screening period, the two consecutive laboratory hemoglobin (Hb) values obtained at least 7 days apart should be <= 100 g/L for the subjects who were receiving erythropoiesis-stimulating agent (ESA) treatment at the time of enrollment, or <= 100 g/L for the subjects who were not receiving ESA treatment at the time of enrollment.
Exclusion criteria
Exclusion criteria: 1.New York Heart Association (NYHA) Class III or IV congestive heart failure; history of myocardial infarction, acute coronary syndrome, stroke, epilepsy, or thrombo/thromboembolic events (e.g., deep venous thrombosis or pulmonary embolism) within 12 weeks prior to randomization; 2.History of chronic liver disease (e.g., chronic infectious hepatitis, chronic autoimmune liver disease, liver cirrhosis, or liver fibrosis); 3.Known hereditary hematological diseases, such as thalassemia, sickle cell anemia, history of pure red cell aplasia, or other known causes of non-chronic kidney disease (CKD) anemia; 4.Known history of kidney cancer, prostate cancer, breast cancer, or any other malignant tumors, except for the following: cancers confirmed to be cured or in remission for more than 5 years, basal cell or squamous cell skin cancer with radical resection, carcinoma in situ of the cervix, or resected colon polyps; 5.Known chronic inflammatory diseases, such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, or inflammatory bowel disease, etc. 6.Known arrangement of a surgery that may cause significant blood loss during the study period; 7.Known hemorrhagic diseases in various forms; 8.Pregnant or lactating women; 9.Known allergy to the study drug or any of its components; 10.Receipt of red blood cell or whole blood transfusion within 4 weeks prior to randomization; 11.Presence of any active infection requiring antibiotic treatment within 4 weeks prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in inflammatory response indicators;Hemoglobin achievement rate and time to achievement;Changes in iron metabolism-related indicators; | — |
Countries
China
Contacts
Public ContactQiongzhen Lin
The First Hospital of Hebei Medical University
Outcome results
None listed