The study, named EPICK is designed to demonstrate that PhosLo (calcium acetate) is effective and safe in controlling elevated phosphorus levels (hyperphosphatemia) in stage 4 chronic kidney disease (CKD) patients without causing very low calcium levels (hypocalcemia), or high levels of acidity in the blood (metabolic acidosis).
Results from the EPICK study will be used to support license applications in the US and the European Union for the use of PhosLo in these pre-dialysis patients.
PhosLo is a prescription phosphate binder currently indicated for the control of hyperphosphatemia in patients with end- stage renal disease (ESRD). Nabi currently markets PhosLo in the US and has filed a marketing authorization application (MAA) to market the product in Europe for the ESRD indication.
“Starting treatment with a cost-effective phosphate binder, like PhosLo, in pre-dialysis patients should help drive market share overall,” noted LeRoux Jooste, senior vice president of global sales and marketing at Nabi. “We would expect physicians to continue to prescribe PhosLo when these stage 4 patients eventually progress to the dialysis stage.”