drugset / Trial / NCT03644264
PA21 Safety and Efficacy in Adult Chinese Subjects
RandomizedParallel-groupOpen-labelTreatment
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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PA21 | Unknown | 1000 mg | — |
| Subject | PA21 | Unknown | 1500 mg | — |
| Subject | PA21 | Unknown | 3000 mg | — |
| Comparator | sevelamer | Other / unclassified | 2.4 g | — |
| Comparator | sevelamer | Other / unclassified | 14.4 g | — |