Pivotal phase III study achieves primary and secondary endpoints

09.07.2012 10:28

The results of a pivotal Phase III clinical trial show that the new phosphate binder PA21 successfully controls hyperphosphatemia in dialysis patients with chronic kidney failure. The study examined the use of PA21 (ferric oxyhydroxide) in the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) undergoing dialysis. The study met its primary and secondary endpoints and will now serve as the basis for registration applications in the US, Europe and Switzerland.

PA21 is an iron based Phosphate binder in the form of a chewable tablet, which consists of polynuclear iron (III) oxyhydroxide, starch and sucrose. The results of the six-month study, which included over 1,000 patients in the USA and Europe as well as in Russia, Ukraine and South Africa, demonstrated the superiority of maintenance dose of PA21 over inactive low-dose PA21 in maintaining the phosphate-lowering effect in dialysis patients. In addition, PA21 proved to be in reducing serum phosphate levels after twelve weeks of treatment as equivalent to Sevelamer carbonate, a current standard of care. An average of three to four PA21 tablets were administered per day (compared to eight to nine sevelamer carbonate). PA21 appears to be generally well tolerated and effective and offers the advantage of requiring fewer tablets to be taken per day.

Hyperphosphatemia causes an increase in blood phosphate levels and is a common, serious condition in patients with chronic kidney failure, particularly in those undergoing dialysis treatment. Although all dialysis patients are treated with phosphate binders, fewer than 50% can achieve and maintain their target phosphate levels. Hyperphosphatemia is a risk factor for complications in CKD patients, such as cardiovascular disease, secondary hyperparathyroidism, and renal osteodystrophy.

The results of the study will serve as the basis for registration applications in the USA, Europe and Switzerland. The first application for approval is scheduled for the fourth quarter of 2012.

The full results of the Phase III study will be presented at Kidney Week American Society of Nephrology (ASN) submitted for presentation. The convention will take place October 30-November 4, 2012 in San Diego, California. The results are also submitted to peer-reviewed journals.