Anemia
Conditions
Interventions
Experimental group:Administer Pemostim via injection.
Control group:Roxadustat Capsules
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18-80 years, weight >= 45 kg, any gender; 2. Diagnosed with chronic kidney disease and has received peritoneal dialysis treatment for >= 3 months prior to selection, with no planned changes to the dialysis method during the trial; 3. Receiving roxadustat treatment for >= 4 weeks before randomization, with an average weekly dose = 80 g/L and = 100 ng/mL during the screening period; 6. Corrected QT interval (QTc) on electrocardiogram within 1 month before enrollment < 500 ms; 7. Blood potassium <= 5.5 mmol/L before enrollment; 8. Willing to switch to pemossaltide (with a switching interval of no less than 5 half-lives of roxadustat: half-life of roxadustat in dialysis patients is approximately 10-12 h) or continue the original roxadustat regimen (continuing treatment interval no less than 5 half-lives of roxadustat); 9. Understands the study procedures and voluntarily signs the written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with known active malignancy (active malignancy must be excluded; patients with non-active malignancy may be enrolled, defined as having undergone no surgery, radiotherapy, or chemotherapy within the past 3 years and showing no current signs of recurrence). 2.Patients with anemia caused by autoimmune diseases or hematologic disorders (including congenital and acquired conditions, such as thalassemia, pure red cell aplasia, myelodysplastic syndrome, hemolytic anemia, etc.). 3.Currently have a clear etiology of anemia other than CKD (e.g., gastrointestinal bleeding such as persistent fecal occult blood positivity, hemorrhagic disorders such as hemophilia, etc.). 4.During the screening period, cardiac function is assessed as NYHA Class III or IV, or acute myocardial infarction occurred within 2 months prior to enrollment. 5.Known decompensated cirrhosis, or any of the following abnormalities within 6 months prior to enrollment (ALT >= 2 times the upper limit of normal, AST >= 2 times the upper limit of normal, DBIL >= 2 times the upper limit of normal, or serum albumin (ALB) below 30 g/L). 6.Received red blood cell or whole blood transfusion within 12 weeks prior to the trial. 7.The investigator determines that a significant infection occurred within 4 weeks prior to randomization. 8. In blood pressure measurements that can be confirmed within 4 weeks prior to enrollment, under conditions of rest and alertness using standard measurement methods, at least 3 blood pressure values on different days must reach or exceed a systolic blood pressure (SBP) of >=180 mmHg and/or a diastolic blood pressure (DBP) of >=110 mmHg, or require changes in antihypertensive drug therapy. The judgment is mainly based on blood pressure values measured in the clinic, but 'white coat hypertension' must be excluded; 9.Patients scheduled for elective surgery during the trial period. 10.The investigator considers the presence of any other factors that make participation in this trial unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 16 weeks of treatment, the average change in Hb levels from baseline in the two groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with Hb of 100–120 g/L and Hb of 110–130 g/L at each follow-up point during the trial period;Proportion of subjects in both groups at each follow-up point during the trial period with an average Hb level >=100 g/L or >=110 g/L;Stratification of average Hb levels in the two groups at each follow-up point during the trial period (80 and 100 and 110 and 130 g/L);Changes in absolute Hb values and changes in Hb levels from baseline at each follow-up point during the trial period;Average medication dosage for subjects with Hb of 100-120 g/L in each group at each follow-up point during the trial period;During the treatment period, the dosage of the investigational drug used between each pair of visits in the two groups; | — |
Countries
China
Contacts
Public ContactChen Limeng
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed