PA21 Safety and Efficacy in Adult Chinese Subjects

Summary

This study evaluates the efficacy of PA21 in comparison with sevelamer carbonate (Renvela®) in lowering and maintaining serum phosphorus in adult Chinese subjects with CKD on dialysis after 12 weeks of treatment.

Timeline

Start

2018-08-31

Primary completion

2020-08-21

Completion

2020-08-21

Outcome

Met primary endpoint

paper with the lower limit of 95% CI above the non-inferiority margin of -0.34 mmol/L. PMID 37473746 ↗

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.
• Liu J, Zuo L, Walpen S, Bernard L, Marty M, Enoiu M. Efficacy and Safety of Sucroferric Oxyhydroxide Compared with Sevelamer Carbonate in Chinese Dialysis Patients with Hyperphosphataemia: A Randomised, Open-Label, Multicentre, 12-Week Phase III Study. Nephron. 2024;148(1):22-33. doi: 10.1159/000531869. Epub 2023 Jul 20.

Drugs

Indications