Approval Probability
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Adjusted LOA
ML Risk
Also known as sucroferric oxyhydroxide, Velphoro®
PA21 · 3 trials · 2 indications
Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Change from baseline in serum phosphorus levels at Week 12: comparison between PA21 group and sevelamer carbonate group.
| Arm | Type | Description |
|---|---|---|
| PA21 (2.5 g tablet) | EXPERIMENTAL | - |
| Sevelamer carbonate | ACTIVE_COMPARATOR | - |
| PA21-1 (1.25 g tablet) | OTHER | - |
| PA21 | EXPERIMENTAL | - |
| PA21 tablets containing 500 mg of iron | EXPERIMENTAL | PA21 chewable tablets standardised to contain 500 mg of iron. PA21 500 mg (iron) chewable tablet contains approximately 2.5 g PA21 drug substance (sucroferric oxyhydroxide). Starting dose will be 1,500 mg/day (3 tablets/day (1 tablet per meal)). Dose increases or decreases of 500 mg/day (1 tablet/day) are permitted. The maximum dose of PA21 will be 3,000 mg/day (6 x 500 mg tablets/day) and the minimum dose will be 1,000 mg/day (2 x 500 mg tablets/day). |
| Sevelamer carbonate: Renvela® tablets | ACTIVE_COMPARATOR | Starting dose will be 2.4 g/day (3 tablets/day). Dose increases or decreases of 2.4 g/day (3 tablets/day (1 tablet per meal)) The maximum dose of sevelamer carbonate will be 14.4 g/day (18 tablets/day) and the minimum dose will be 2.4 g/day (3 tablets/day). |
| Name | Type | Description |
|---|---|---|
| PA21 (2.5 g tablet containing 500 mg iron) | DRUG | Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day). |
| Sevelamer carbonate | DRUG | Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day) |
| PA21-1 (1.25 g tablet containing 250 mg iron) | DRUG | Low dose comparator (1.25 g/day) |
| PA21 | DRUG | sucroferric oxyhydroxide is a mixture of polynuclear iron(III)-oxyhydroxide (about 33% m/m), sucrose (about 30% m/m), and starches (about 28% m/m) and contains ≤10% m/m water. |
Inclusion Criteria: * Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL) * Stable dose of phosphate binder * Written informed consent Exclusion Criteria: * Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH) * Other significant medical conditions * Pregnancy
PA21 is an investigational phosphate binder being developed for people with chronic kidney disease who require chronic dialysis. It is designed to control hyperphosphatemia, the elevated blood phosphate levels common in dialysis patients. PA21 is a small molecule and is not yet approved; it remains in Phase 3 clinical development.
PA21 is being developed by Fresenius Medical Care AG, which trades under the ticker FMS. The company is the sponsor of the Phase 3 clinical program evaluating PA21 in dialysis patients with chronic kidney disease.
PA21 is in Phase 3 clinical development. Three Phase 3 trials have been registered, and all three are listed as completed. The program has enrolled a total of 2,004 participants across these studies, and PA21 is not approved for commercial use.
PA21 has been studied in three Phase 3 trials: NCT01324128, a 1,059-patient safety and efficacy study in dialysis patients; NCT01464190, a 659-patient long-term extension study; and NCT03644264, a 286-patient safety and efficacy study in adult Chinese subjects. All three trials are completed.