For patients with renal anemia treated with hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), there is a clinical need of switching to long-acting and safe medications.
Pegmolesatide, a polyethylene glycol (PEG)-conjugated erythropoiesis-stimulating peptide, is a long-acting erythropoiesis-stimulating agent (ESA) with sustained activity. It was approved for marketing by the National Medical Products Administration (NMPA) in June 2023. Phase III clinical trials have demonstrated its efficacy and safety in dialysis patients with renal anemia who were previously treated with recombinant human erythropoietin (rHuEPO). However, there are currently no data regarding the efficacy and safety of switching from HIF-PHIs to pegmolesatide, and there is a lack of standard for the dose conversion.
This study is a multi-center, prospective, open-label, randomized parallel-controlled clinical trial, planning to enroll 96 patients.
All enrolled patients will receive 12 weeks of treatment and be followed up for 16 weeks.
Age between 18-75 years, regardless of gender;
Body weight ≥ 45 kg, and body mass index (BMI) ≥ 18.5 kg/m²;
Diagnosis of chronic renal failure, and having undergone a stable regimen of peritoneal dialysis or hemodialysis for at least 12 weeks prior to enrollment (with stable hemofiltration at a frequency of every 2 or 4 weeks if applicable). Stable dialysis frequency and no plans to change the dialysis modality during the trial;
An up to standard dialysis adequacy testing result before randomization: spKt/V ≥ 1.2 for hemodialysis, Kt/V ≥ 1.7 for peritoneal dialysis;
Known autoimmune diseases, hematologic disorders (including congenital and acquired conditions such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndrome, hemolytic anemia, and coagulation disorders), or other causes of anemia apart from CKD (such as gastrointestinal bleeding or hookworm disease).
Confirmed diagnosis of acquired immunodeficiency syndrome (AIDS), syphilis, or tuberculosis and currently undergoing treatment.
Known allergy to iron agents or polyethylene glycol molecules.
Treatment history with ESAs in combination with HIF-PHIs drugs within 8 weeks prior to randomization.
Parallel
Pegmolesatide 2mg SC
DrugAll patients will receive pegmolesatide 2mg subcutaneously once every 4 weeks.
Pegmolesatide 4mg SC
DrugAll patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.
Pegmolesatide 4mg SC
DrugAll patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.
Pegmolesatide 6mg SC
DrugAll patients will receive pegmolesatide 6mg subcutaneously once every 4 weeks.
Change of mean HB level
Change of mean HB level from baseline to 12 weeks and 16 weeks
Change of mean HB level
Change in mean HB levels from baseline to 12 weeks and 16 weeks, stratified by different baseline HB levels
Changes in red blood cell count
Changes in red blood cell count from baseline to each follow-up
Median time to the first HB value reaching 10.0-12.0 g/dl
Median time to the first HB value reaching 10.0-12.0 g/dl
Proportion of patients with HB 10.0-12.0 g/dl
Proportion of patients with HB 10.0-12.0 g/dl at each follow-up
The Maximum Plasma Concentration
The Maximum Plasma Concentration of Pegmolesatide
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