This study is a prospective, multicenter, parallel-controlled, open-label clinical trial, planned to be conducted across multiple research centers in various provinces and cities in China.
It will enroll 240 dialysis-dependent chronic kidney disease (DD-CKD) patients with anemia who have been receiving rHuEPO treatment for at least 4 weeks, with hemoglobin (Hb) levels of ≥70 g/L and \<110 g/L. After enrollment, participants will be randomly assigned in a 1:1:1 ratio to the experimental group, control group, and exploratory group. The study will involve a 24-week treatment and observation period, divided into three phases: a screening period (Day -28 to Day -1), a treatment period (Week 0 to Week 16), and an extension period (Week 17 to Week 24).
The primary objective is to assess the impact of the three treatment regimens on the hemoglobin levels of patients with DD-CKD anemia.
Aged ≥18 years and ≤80 years, with no restrictions on gender.
Body weight ≥40 kg and body mass index (BMI) ≥18 kg/m².
Subjects who have received hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment;
Subjects who have been receiving erythropoiesis-stimulating agents (ESAs) for ≥4 weeks prior to randomization, with an average weekly dose >6000 IU in the last 4 weeks (equivalent dose converted to short-acting EPO >6000 IU, calculated as the total amount of short-acting EPO used in the last 4 weeks divided by 4);
Known to have active malignancy, polycystic kidney disease, hematologic disorders (including congenital and acquired anemias such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndromes, hemolytic anemia, and coagulation disorders), or other causes of anemia (such as gastrointestinal bleeding or hookworm disease);
Known to have experienced stroke, transient ischemic attack, myocardial infarction, thromboembolic events (deep vein thrombosis), pulmonary embolism, or other serious cardiopulmonary diseases within the past 6 months;
Received anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization;
Known to have received red blood cell or whole blood transfusion within 12 weeks prior to the study.
Parallel
The rHuEPO Monotherapy Group (Control Group)
DrugThe rHuEPO Monotherapy Group (Control Group) will be treated with rHuEPO for the first 16 weeks and then switch to Pegmolesatide treatment for the subsequent 8 weeks.
The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group)
DrugThe Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group) will receive a combination of Pegmolesatide and roxadustat throughout the entire 24-week treatment period.
The Pegmolesatide Monotherapy Group (Experimental group)
DrugThe Pegmolesatide Monotherapy Group (Experimental Group) will receive Pegmolesatide treatment throughout the entire 24-week period.
The change in mean hemoglobin (Hb) levels from baseline at weeks 12 to 16 of treatment in the three groups.
Primary efficacy endpoints
The proportion of participants in the three groups with mean Hb levels ≥100 g/L and ≤120 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment.
secondary efficacy endpoints
The proportion of participants in the three groups with mean Hb levels ≥110 g/L and ≤130 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment.
secondary efficacy endpoints
The proportion of participants in the three groups with mean Hb levels ≥100 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment.
secondary efficacy endpoints
The proportion of participants in the three groups with mean Hb levels ≥110 g/L at weeks 12 and 24 of treatment.
secondary efficacy endpoints
Artificial intelligence (AI)-predicted rational dosing regimens for medications.
Upon completion of the experiment and collection of relevant data from the participants, we will employ artificial intelligence and machine learning techniques to model and train our database. This process will involve the development of an artificial intelligence-based predictive model. This model will be capable of forecasting individual patients' needs for peginesatide to maintain hemoglobin (Hb) levels within the target range, as well as predicting monthly dose adjustments for peginesatide. Ultimately, this approach aims to optimize anemia management in patients with chronic kidney disease (CKD).
The change in carbamylated EPO levels from baseline at week 16 of treatment in the three groups.
Exploratory endpoints
Subgroup analysis based on different baseline characteristics
Exploratory endpoints
Thromboembolic events: It is necessary to distinguish whether the thromboembolic events are related to blood vessels or catheters, and to identify whether they are caused by thrombus formation.
Safety endpoints
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Chinese PLA General Hospital
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Collaborator
