Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
low-dose sucroferric oxyhydroxide · 1 trial · 1 indication
The primary outcome is change in the mean T50- Test values between different study phases (wash-out/treatment/control).
| Arm | Type | Description |
|---|---|---|
| low-dose sucroferric oxyhydroxide | ACTIVE_COMPARATOR | Low dose 250 mg sucroferric oxyhydroxide (PA21) per day (1x 250mg tablets/day) for 14 days. |
| high-dose sucroferric oxyhydroxide | ACTIVE_COMPARATOR | Uniform dose 2000 mg of sucroferric oxyhydroxide (PA21) per day (4x 500mg tablets/day) for 14 days |
| Name | Type | Description |
|---|---|---|
| low-dose sucroferric oxyhydroxide | DRUG | 250 mg suroferric oxyhydroxide |
| high-dose sucroferric oxyhydroxide | DRUG | 2000 mg suroferric oxyhydroxide |
Inclusion Criteria: * Prevalent patients (≥ 3 months on dialysis) treated with thrice weekly hemodialysis (HD) or hemodiafiltration (HDF) * Hyperphosphatemia (serum phosphate \> upper limit of normal within the last 3 months) or current phosphate binder use * No use or constant dose of vitamin D an...
Low-dose sucroferric oxyhydroxide is used for endstage renal disease, specifically to lower phosphate levels in the blood. It is being studied as a phosphate binder in patients with this condition, with the goal of reducing calcification propensity of serum.
Low-dose sucroferric oxyhydroxide is being developed by Fresenius Medical Care AG, a company traded under the ticker FMS. The drug is currently in Phase 2 clinical development for endstage renal disease.
Low-dose sucroferric oxyhydroxide is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 2 trial has been completed, involving 40 patients with endstage renal disease.
Low-dose sucroferric oxyhydroxide has one completed clinical trial, NCT03010072, titled 'The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum.' This Phase 2 study enrolled 40 patients with endstage renal disease in Austria.
Yes, low-dose sucroferric oxyhydroxide is also known as PA21, as indicated in the clinical trial title. The study NCT03010072 refers to the drug as sucroferric oxyhydroxide (PA21), confirming that these names refer to the same compound.