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www.fdanews.com/articles/72176-nabi-initiates-phoslo-epick-study-in-chronic-kidney-disease-patients

Nabi Initiates PhosLo Epick Study in Chronic Kidney Disease Patients

May 11, 2005

Nabi Biopharmaceuticals has initiated its PhosLo (calcium acetate) EPICK study in chronic kidney disease (CKD) patients suffering from Stage 4 kidney disease.

The study is designed to demonstrate that PhosLo is effective and safe in controlling elevated phosphorus levels (hyperphosphatemia) in Stage 4 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 U.S. 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). The company currently markets PhosLo in the U.S. and has filed a marketing authorization application to market the product in Europe for the ESRD indication.