Kidney Week

Abstract: TH-PO1200

52-Week Phase 3 Study to Evaluate the Efficacy and Safety of a Novel Iron-Based Phosphate Binder AP301 in Patients on Dialysis with Hyperphosphatemia

Session Information

• Late-Breaking Research Posters
  November 06, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Bone and Mineral Metabolism

• 502 Bone and Mineral Metabolism: Clinical

Authors

• Zuo, Li, Peking University People's Hospital, Beijing, China

Li Zuo, MD, PhD

• Gan, Liangying, Peking University People's Hospital, Beijing, China

Liangying Gan, MD

• Bi, Guangyu, Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China

Guangyu Bi, APN, ScD

• Xu, Jinsheng, The Fourth Affiliated Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

Jinsheng Xu

• Ye, Hong, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Hong Ye, MD

• Mao, Huijuan, The First Affiliated Hospital With Nanjing Medical University, Nanjing, Jiangsu, China

Huijuan Mao, MD, PhD

• Dai, Hou-yong, Affiliated Hospital of Nantong University, Nantong, Jiangsu, China

Hou-yong Dai

• Wang, Pei, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

Pei Wang, MD

• Gao, Qing, Zhongshan Hospital Xiamen University, Xiamen, Fujian, China

Qing Gao

• Chen, Yuqing, Peking University First Hospital, Beijing, China

Yuqing Chen, MD

• Li, Yi, Dongguan People's Hospital,The Tenth Affiliated Hospital of Southern Medical University, Dongguan, Guangdong, China

Yi Li, MD

• Huang, Jiyi, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China

Jiyi Huang, PhD

• Xu, Yan, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China

Yan Xu

• Lin, Hong Li, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China

Hong Li Lin, MD

• Zhong, Aimin, Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, China

Aimin Zhong, MBBS

• Ding, Jiaxiang, Peking University International Hospital, Beijing, China

Jiaxiang Ding

• Chen, Jing, Huashan Hospital Fudan University, Shanghai, China

Jing Chen, MD, PhD

• Chi, Yanqing, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

Yanqing Chi, MD

• Zheng, Hui Xiao, The Second Affiliated Hospital of Xingtai Medical College, Xingtai, Hebei, China

Hui Xiao Zheng

• Liu, Bin, Wuxi People's Hospital, Wuxi, Jiangsu, China

Bin Liu, MD

• Zhang, Xiaoliang, Southeast University Zhongda Hospital, Nanjing, Jiangsu, China

Xiaoliang Zhang, MD, PhD

• Shi, Ming, Wuhan University Renmin Hospital, Wuhan, Hubei, China

Ming Shi, MD

• Li, Yuehong, Beijing Tsinghua Changgung Hospital, Beijing, China

Yuehong Li, MD

• Liu, Yingxue Cathy, Shanghai Alebund Pharmaceuticals Co Ltd, Shanghai, China

Yingxue Cathy Liu, PhD

• Xia, Gavin G., Shanghai Alebund Pharmaceuticals Co Ltd, Shanghai, China

Gavin G. Xia, PhD

Background

AP301 (acacia-ferric oxyhydroxide) is a novel non-absorbed iron-based phosphate binder with no chewing need.

Methods

In this active controlled study (NCT07030595), hemo- and peritoneal dialysis patients with baseline serum phosphate (s-P) 6.0-10.0 mg/dL were randomized 3:1 to AP301 (2.1–9.1 g/d) or sevelamer carbonate (SEV) (2.4–9.6 g/d); doses were given TID with meals, titrated to keep s-P 3.5-5.5 mg/dL. AP301 responders (s-P<5.5 mg/dL) at Week 24 were re-randomized 1:1 to maintenance dose (MD) or ineffective low dose (LD) (0.375 g/d) for 3 weeks. The study assessed AP301's non-inferiority to SEV at Week 12 and MD's superiority over LD of AP301 in the randomized withdrawal phase at Weeks 24-27 for s-P control, as well as its safety and tolerability.

Results

Of 474 randomized patients, 396 (84%) completed the study. At Week 12, mean s-P change (±SE) from baseline was –2.2±0.1 (AP301) vs -2.2±0.1 (SEV) mg/dL, revealing non-inferiority (upper 95% CI limit 0.19 mg/dL<NIM of 0.59 mg/dL). At Week 27, the primary endpoint showed clinically significant superiority of MD vs LD (LSM difference –1.8 mg/dL [95% CI: –2.1, –1.5; P<0.001]) (Fig 1A). Efficacy of AP301 was maintained until Week 52 (Fig 1). TEAEs were comparable (AP301 96%, SEV 91%). Discolored feces (34%) and diarrhea (17%) were more frequent with AP301, mostly early onset (Fig 2). Nausea (4%) and constipation (3%) were more frequent with SEV. Mild, non-clinical meaningful changes of iron parameters were observed through Week 24, with no evidence of iron accumulation.

Conclusion

This novel iron-based phosphate binder AP301 effectively lowered s-P in dialysis patients with an acceptable safety and tolerability profile.

Funding

• Commercial Support – Shanghai Alebund Pharmaceuticals Limited

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.202556bnmcy8