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Abstract: SA-PO172

A Phase 2 Dose Ranging Study to Evaluate the Efficacy, Tolerability, and Safety of VS-505 in Hemodialysis Patients With Hyperphosphatemia

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Zhuang, Bing, Nanjing Medical University, Nanjing, Jiangsu, China
  • Liu, Bin, Wuxi People's Hospital, Wuxi, Jiangsu, China
  • Gan, Liangying, Peking University People's Hospital, Beijing, China
  • Yuan, Wei jie, Shanghai General Hospital, Shanghai, China
  • Shi, Ming, Wuhan University Renmin Hospital, Wuhan, Hubei, China
  • Peng, Ai, Shanghai Tenth People's Hospital, Shanghai, China
  • Wang, Lihua, Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China
  • Chen, Xiaolan, Affiliated Hospital of Nantong University, Nantong, China
  • Liu, Tongqiang, The Affiliated Changzhou No 2 People's Hospital of Nanjing Medical University, Changzhou, Jiangsu, China
  • Zhang, Shiying, Jilin Province People's Hospital, Changchun, Jilin, China
  • Liu, Hua Chang, Northern Jiangsu People's Hospital, Yangzhou City, Jiangsu Province, China
  • Gao, Qing, Zhongshan Hospital Xiamen University, Xiamen, China
  • Wang, Baoxing, Hebei Medical University Third Affiliated Hospital, Shijiazhuang, Hebei, China
  • Zheng, Hui Xiao, The Second Affiliated Hospital of Xingtai Medical College, Xingtai, Hebei, China
  • Wang, Song, Peking University Third Hospital, Beijing, China
  • Lin, Li Hong, First Affiliated Hospital of Dalian Medical University, Dalian, Dalian, China
  • He, Qiang, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
  • Zheng, Feng, The Second Hospital of Dalian Medical University, Dalian, Liaoning, China
  • Luo, Ping, Jilin University Second Hospital, Changchun, Jilin, China
  • Long, Gang, Tianjin People's Hospital, Tianjin, China
  • Lu, Wei, Shanghai Jiaotong University School of Medicine Xinhua Hospital, Shanghai, China
  • Li, Kanghui, Guilin Medical University Affiliated Hospital, Guilin, Guizhou, China
  • Yang, Junwei, Nanjing Medical University, Nanjing, Jiangsu, China
  • Liu, Yingxue Cathy, Alebund Biotech Inc., Shanghai, China
  • Zuo, Li, Peking University People's Hospital, Beijing, China
Background

VS-505 is a novel non-absorbed phosphate binder with the component of iron and gum Arabic. This was a phase II, 6-week open-label, randomized, active controlled dose-ranging study in hemodialysis (HD) patients with hyperphosphatemia. The primary objective was to investigate the ability of different fixed dose of VS-505 to lower serum phosphorus in this population.

Methods

Adult HD patients with serum phosphorus level between 6 - 10 mg/dL were randomized to VS-505 at dosages of 1.50, 2.25, 4.50, 6.75 g/d or sevelamer 4.80 g/d divided into 3 times administered orally with meals for 6 weeks. No dose titration was allowed. Patients were withdrawn if their serum phosphorus > 8.5mg/dL or < 2.5mg/dL during the treatment.

Results

There were 133 patients randomized, 131 received the study drugs and 108 patients completed 6-week treatment. A statistically significant decrease in serum phosphorus level from baseline to end of treatment were observed in all VS-505 and sevelamer groups (Table 1). No significant changes of serum calcium, iPTH and iron parameters were observed during the treatment phase.
In pooled VS-505 groups, 81.0% patients reported ≥ 1 TEAE; discolored feces (51.4%) and diarrhea (10.5%) were most common TEAEs. No SAE was related to VS-505 as assessed by the investigator. 4.8% of VS-505 and 3.8% of sevelamer treated patients discontinued treatment due to AEs.

Conclusion

The dose-dependent serum phosphorus lowering effect of VS-505 has been demonstrated. VS-505 4.50 g/d, 6.75g/d and sevelamer 4.80 g/d groups showed clinically significant serum phosphorus reduction. VS-505 was safe and well tolerated in HD patients with hyperphosphatemia.
ClinicalTrials.gov Identifier: NCT04551300.

Table 1. Change in serum phosphorus from baseline to end of treament