Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PA21 · 3 trials · 2 indications
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 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
Change from baseline in serum phosphorus levels at Week 12: comparison between PA21 group and sevelamer carbonate group.
| Arm | Type | Description |
|---|---|---|
| PA21 | EXPERIMENTAL | - |
| Sevelamer carbonate | ACTIVE_COMPARATOR | - |
| PA21 (2.5 g tablet) | EXPERIMENTAL | - |
| PA21-1 (1.25 g tablet) | OTHER | - |
| 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 | Film coated, compressed tablets. 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: * Subjects who have completed treatment in Protocol PA-CL-05A * Written Informed Consent Exclusion Criteria: * Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH) * Other significant medical conditions * Pregnancy
PA21 is an investigational small molecule phosphate binder being developed for chronic kidney disease requiring chronic dialysis. It is designed to manage hyperphosphatemia, or elevated blood phosphate levels, in adult dialysis patients. The drug has been studied in Phase 3 clinical trials, but it is not yet approved and remains in clinical development.
PA21 is being developed by Fresenius Medical Care AG, a German dialysis company traded on the New York Stock Exchange under the ticker FMS. The company has sponsored multiple Phase 3 clinical trials of PA21 in dialysis patients across the United States, Europe, and Asia.
PA21 is in Phase 3 clinical development. Three Phase 3 trials have been completed, with a total enrollment of 2,004 patients. The drug is investigational and has not been approved by regulatory authorities. All three trials are completed, and no active trials are currently listed.
PA21 has completed three Phase 3 trials: NCT01324128, a safety and efficacy study in 1,059 dialysis patients; NCT01464190, a long-term extension study in 659 patients; and NCT03644264, a safety and efficacy study in 286 Chinese patients with hyperphosphatemia. All trials were completed and enrolled adults aged 18 years and older.
PA21 is a phosphate binder developed by Fresenius Medical Care. No alternative names for PA21 have been disclosed in the clinical trial records. The drug is being studied under the name PA21 across all its Phase 3 trials, including the extension study and the Chinese patient study.