drugset / Trial / NCT07030595
AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia
RandomizedParallel-groupOpen-labelTreatment
Summary
This Phase 3 clinical trial is the pivotal study of AP301 aiming to evaluate the efficacy and safety of AP301 for controlling serum phosphorus in chronic kidney disease receiving hemodialysis and peritoneal dialysis in Chinese patients with hyperphosphatemia.
Timeline
- Start
- 2023-06-12
- Primary completion
- 2024-10-02
- Completion
- 2025-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AP301 | Unknown | 0.375 g | Oral |
| Subject | AP301 | Unknown | 2.1 g | Oral |
| Subject | AP301 | Unknown | 9.1 g | Oral |
| Comparator | sevelamer | Other / unclassified | 2.4 g | Oral |
| Comparator | sevelamer | Other / unclassified | 9.6 g | Oral |