Anemia
Conditions
Interventions
Loncipoetin alfa Injection (SSS06) QOW Group:Loncipoetin alfa Injection
Recombinant Human Erythropoietin Injection (CHO Cell) Group:Recombinant Human Erythropoietin Injection
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Understand the research procedure and voluntarily sign the Informed Consent Form (ICF) in writing; 2.Males or females aged between 18 and 75 (inclusive) at the time of signing the ICF; 3.Those who have not yet received dialysis treatment plan to start within 4 weeks; for those who have already undergone dialysis, they are CKD end-stage renal disease patients who have been receiving dialysis treatment for =4 weeks and all plan to continue dialysis treatment during the study period; 4.During the screening period, the hemoglobin (Hb) level should be greater than 60g/L and less than 100g/L (inclusive); 5.Transferrin saturation (TSAT) = 20% and serum ferritin (SF) = 100 µg/L; serum folate level = lower limit of normal value, vitamin B12 = lower limit of normal value; 6.Subjects agree that they and their spouses have no plans to conceive from the time of signing the informed consent form until 3 months after the end of the study, and are willing to adopt effective contraceptive measures;
Exclusion criteria
Exclusion criteria: 1.Individuals who are allergic to the trial drug or any of its components, or who have previously experienced a severe allergic reaction to a drug; 2.In addition to renal anemia, there are other diseases that can cause chronic anemia (such as sickle cell anemia, hematological malignancies, hemolytic anemia, pure red cell aplasia), hematological diseases, and coagulation dysfunction; 3.Patients who are scheduled to undergo other surgical procedures during the study period (primarily referring to major surgeries; surgeries with minimal blood loss that do not affect Hb concentration are not included in this scope); 4.Individuals who have experienced acute or chronic blood loss (such as upper gastrointestinal bleeding) within the three months prior to enrollment, as well as those who have undergone minor surgeries such as the establishment of a "temporary vascular access" due to clinical medical procedures, are not included in this scope; 5.Patients with a history of malignant hypertension or poorly controlled hypertension (systolic blood pressure > 180mmHg or diastolic blood pressure > 100mmHg); 6.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels are greater than three times the upper limit of normal; blood biochemical examination shows albumin levels less than 25g/L; 7.Patients with severe secondary hyperparathyroidism (iPTH/PTH > 1000 ng/L); 8.ndividuals with a history of thromboembolic diseases (excluding cerebral lacunar infarction and dialysis access thrombosis), severe hematopoietic system diseases, and a tendency towards hypercoagulability; 9.Individuals with severe cardiovascular and cerebrovascular diseases, severe or unstable coronary artery disease, heart failure (NYHA class III or IV), or those who have experienced myocardial infarction or stroke within the previous 3 months prior to enrollment; 10.History of malignant tumor, except for the following conditions: confirmed cure or no recurrence within 5 years, radical excision of basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ in any location; 11.Researchers determined that participants had severe infectious diseases or chronic, uncontrollable inflammation within 4 weeks before enrollment; 12.All individuals with epilepsy or a history of epilepsy, except those with febrile seizures in childhood, single episodes following trauma, or single episodes following abstinence from alcohol; 13.Individuals who have received androgen therapy or blood transfusion therapy within 8 weeks prior to enrollment; 14.Those who have had a cardiac pacemaker implanted for more than 5 years; if the duration is less than or equal to 5 years, and the assessment and testing of the cardiac pacemaker's working status are unqualified; 15.Within 3 months, the subject has participated in other drug clinical trials or has discontinued the medication less than 5 half-lives of the trial drug at the time of enrollment (whichever is longer); 16.Subjects who were in the middle of pregnancy or lactation at the time of enrollment; 17.Alcoholics, drug addicts, or individuals with substance abuse issues; 18.Other situations that the researchers judge may make participants unsuitable for this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean corpuscular hemoglobin (Hb) concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in iron metabolism-related indicators; | — |
Countries
China
Contacts
Public ContactCHEN XIAONONG
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed