The 2024 American Society of Nephrology (ASN) Kidney Week conference took place at the San Diego Convention Center from October 23 to 27. During this event, a post-hoc analysis of Hansoh Pharma’s innovative drug, pegmolesatide (trade name: Saint Luolai), for treating anemia in chronic kidney disease (CKD) patients on dialysis was presented in poster format.
This annual meeting is the leading global conference for nephrology, focusing on the latest advancements and research in kidney diseases. This year, it attracted over 12,000 renal professionals from around the world.
Pegmolesatide, a long-acting pegylated erythropoietin mimetic peptide, was approved by the National Medical Products Administration (NMPA) in June 2023 for treating CKD-related anemia and was included in China’s National Reimbursement Drug List (NRDL) the same year.
A prior randomized, multicenter, open-label, non-inferiority phase III trial published in eClinicalMedicine demonstrated the efficacy and safety of pegmolesatide in achieving stable hemoglobin targets with just one subcutaneous injection per month.
The post-hoc analysis results presented at ASN confirmed that pegmolesatide maintained hemoglobin target levels better than short-acting erythropoietins, with a favorable safety profile. Key details include:
Study Profile
- Title: Pegmolesatide for Treating Anemia in CKD Patients Undergoing Dialysis: Insights from a Randomized Active-Controlled Phase 3 Study
- Date: October 24, 2024
- Location: Exhibit Hall, Convention Center
- Abstract Time: 10:00 AM – 12:00 PM
- Category: Anemia and Iron Metabolism
Authors:
- Jianghua Chen, The First Affiliated Hospital of Zhejiang University, China
- Linghui Zhou, The First Affiliated Hospital of Xiamen University, China
- Minghao Guo, The First Affiliated Hospital of Xinxiang Medical University, China
- Hongguang Zheng, General Hospital of Northern Theater Command, China
- Deqiong Xie, Second People’s Hospital of Yibin, China
- Zhizhen Hu, Jiangsu Hansoh Pharmaceutical Co Ltd, China
- Weili Luo, Jiangsu Hansoh Pharmaceutical Co Ltd, China
Background Pegmolesatide has shown comparable efficacy and safety to epoetin alfa based on a phase III study (NCT03902691). This post-hoc analysis aims to explore additional benefits for dialysis patients with anemia.
Methods A total of 372 CKD patients undergoing dialysis were randomized (2:1) to receive either pegmolesatide or epoetin alfa over 52 weeks. The analysis assessed hemoglobin (Hb) levels across various ranges during the efficacy evaluation period.
Results A higher percentage of patients receiving pegmolesatide achieved mean Hb levels of ≥11 g/dL compared to those on epoetin alfa (63.9% vs. 44.7%, P=0.0003). More patients on pegmolesatide maintained Hb levels within the target ranges of 11-12 g/dL (35.2% vs. 22.8%, P=0.0164) and 11-13 g/dL (57.5% vs. 36.8%, P=0.0002). In specific subgroups—such as patients aged ≤65 years, those with primary hypertension, stage 5 CKD for ≥12 months, CRP ≤11.5 mg/L, serum ferritin between 100-500 ng/mL, and transferrin saturation ≥20%—pegmolesatide also showed a greater effect in maintaining Hb levels. Treatment-related adverse events, including hypertension (4.5% vs. 6.5%), hepatotoxicity (0.8% vs. 2.4%), and hyperkalemia (2.4% vs. 4.0%), were numerically lower in the pegmolesatide group.
