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.
For patients with renal anemia treated with HIF-PHIs, 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. Based on the weekly dose of Roxadustat before randomization, patients are divided into two cohorts: the low-dose Roxadustat cohort (weekly dose ≤210 mg) and the high-dose Roxadustat cohort (weekly dose \>210 mg and ≤360 mg), with 48 patients in each cohort. Each cohort is stratified by hemoglobin (HB) level, with a 1:1 ratio for HB \<10.0 g/dl and HB ≥10.0 g/dl, meaning that there are 24 patients in both cohorts. Within each cohort, patients are randomly assigned to 2 groups at a 1:1 ratio based on the initial treatment dose of pegmolesatide. Specifically, the patients in low-dose Roxadustat cohort are randomized into the Pegmolesatide initial dose 2 mg group or 4 mg group; the patients in high-dose Roxadustat cohort are randomized into the Pegmolesatide initial dose 4 mg group or 6 mg group, with 24 patients in each group entering the trial period. Pegmolesatide is administered subcutaneously once every 4 weeks, and the dosage is adjusted according to the drug's instructions for use. All enrolled patients will receive 12 weeks of treatment and be followed up for 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
All patients will receive pegmolesatide 2mg subcutaneously once every 4 weeks.
All patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.
All patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.
All patients will receive pegmolesatide 6mg subcutaneously once every 4 weeks.
Beijing Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGLongyan First Hospital
Longyan, Fujian, China
NOT_YET_RECRUITINGZhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
NOT_YET_RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGChange of mean HB level
Change of mean HB level from baseline to 12 weeks and 16 weeks
Time frame: 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
Time frame: from baseline to 12 weeks and 16 weeks
Changes in red blood cell count
Changes in red blood cell count from baseline to each follow-up
Time frame: from baseline to 4 weeks, 8 weeks, 12 weeks, 16 weeks
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
Time frame: From baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks
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
Time frame: from baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks
Proportion of patients with HB 11.0-13.0 g/dl
Proportion of patients with HB11.0-13.0 g/dl at each follow-up
Time frame: from baseline to 4 weeks, 8 weeks, 12 weeks and 16 weeks
Average drug dose at each follow-up
Time frame: From baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks
Adverse Events
Safety of therapy by Investigator.
Time frame: From the start of study drug to 30 days after the last dose of study drug
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGMeizhou People's Hospital
Meizhou, Guangdong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
NOT_YET_RECRUITINGYuebei People's Hospital
Shaoguan, Guangdong, China
NOT_YET_RECRUITINGZhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong, China
NOT_YET_RECRUITINGAffiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
NOT_YET_RECRUITING...and 14 more locations