A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients

Summary

A multi-center, open-label, parallel-design, active-controlled phase 2 study to evaluate the tolerability, safety and efficacy of various dosages of VS-505 compared with Sevelamer Carbonate when given orally with meal for 6 weeks to treat hyperphosphatemia in chronic kidney disease subjects receiving maintenance hemodialysis.

Timeline

Start

2020-10-13

Primary completion

2022-06-30

Completion

2022-10-15

Publications

• Zhuang B, Gan L, Liu B, Yuan W, Shi M, Peng A, Wang L, Chen X, Liu T, Zhang S, Wang S, Gao Q, Wang B, Zheng H, Liu C, Luo Y, Ye H, Lin H, Li Y, He Q, Zheng F, Luo P, Long G, Lu W, Li K, Yang J, Liu YC, Zhang Z, Li X, Zhang W, Zuo L. Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis. Nephrol Dial Transplant. 2024 Sep 27;39(10):1649-1661. doi: 10.1093/ndt/gfae053.

Drugs

Indications