💬In plain words
What the trial is, and whether it could suit you
This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients which had received Recombinant human erythropoietin (rHuEPO) or Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) treatment were randomized in a 1:1 ratio to receive Pegmolesatide with different administration regimens.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
* Inclusion Criteria:
1. Aged ≥18 years and ≤80 years, regardless of gender;
2. Body weight ≥45 kg; Body Mass Index (BMI) ≥18.5 kg/m²;
3. Diagnosed with chronic kidney disease (CKD) complicated by renal anemia, with an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m² before randomization (GFR estimation using the CKD-EPI formula); Undergoing continuous treatment with rHuEPO or HIF-PHI for ≥2 weeks before randomization;
4. Hemoglobin (Hb) level measured within 7 days before randomization ≥70 g/L and \< 110 g/L;
5. Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF)
* Exclusion Criteria:
1. Known to have hematological disorders or other diseases that cause anemia other than chronic kidney disease (CKD), such as primary pure red cell aplasia (PRCA), homozygous sickle cell disease, thalassemia/Cooley's anemia, multiple myeloma, hemolytic anemia, and myelodysplastic syndrome, or malignant tumors;
2. Known to be allergic to iron agents or polyethylene glycol;
3. Received red blood cell or whole blood transfusion therapy within the three months prior to randomization;
4. Having received or planned to receive anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization or during the study treatment period;
5. Poorly controlled blood pressure (specific criteria for determination are referenced in Appendix II);
6. C-reactive protein (CRP) ≥30 mg/L within 7 days prior to randomization;
7. Pregnant or breastfeeding women, women of childbearing age with a positive urine β-HCG test result prior to the study, or those planning to become pregnant during the study;
8. Assessed as having Class C liver function within 7 days prior to randomization (Child-Pugh classification, details in Appendix IV);
9. Assessed as having Class III or IV cardiac function within 28 days prior to randomization (details in Appendix III);
10. Subjects deemed by the investigator to have any other factors that make them unsuitable for participation in this study.
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