A novel investigational iron-based phosphate binder lowers serum phosphorus levels in dialysis patients with an efficacy similar to that of sevelamer carbonate but with a lower pill burden and better patient adherence, according to study findings published online ahead of print in Kidney International.
In a phase 3 open-label study led by Jürgen Floege, MD, RWTH University Hospital Aachen, Aachen, Germany, 707 hemodialysis and peritoneal dialysis patients received the novel binder sucroferric oxyhydroxide (PA21) 1.0-3.0 g/day and 348 received sevelamer carbonate 4.8-14.4 g/day for an 8-week titration, followed by 4 weeks without dose change, and then 12 weeks maintenance.
The PA21 and sevelamer groups experienced similar decreases in serum phosphorus (0.71 and 0.79 mmol/L, respectively). The results demonstrated non-inferiority of, on average, 3 tablets of PA21 versus 8 tablets of sevelamer. Non-adherence was 15.1% in the PA21 group compared with 21.3% in the sevelamer group.
The proportion of patients reporting at least 1 treatment-emergent adverse event (AE) was higher in the PA21 group than the sevelamer group (83.2% vs. 76.1%). Mild, transient diarrhea, discolored feces, and hyperphosphatemia were more common with PA21, and nausea and constipation were more common with sevelamer, the researchers reported.
A higher proportion of patients in the PA21 group than the sevelamer group withdrew because of treatment-emergent AEs (15.7% vs. 6.6%).