A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

Phase 3 Completed 213 enrolled Kissei Pharmaceutical Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia

Timeline

Start: 2013-04-23
Primary completion: 2013-12
Completion: 2013-12-10

Outcome

Met primary endpoint

registry analysis (non-inferiority test); PA21 vs Sevelamer Hydrochloride; p = 0.020; Mean Difference (Final Values) -0.34 (95% CI -0.63 to -0.05); ANCOVA NCT01850602 ↗

Publications

Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PA21	Unknown	—	—
Comparator	Sevelamer	Other / unclassified	—	—