Nabi Biopharmaceuticals (Nasdaq: NABI) recently announced the positive results from the PhosLo® (calcium acetate) EPICK study in Chronic Kidney Disease (CKD) patients suffering from Stage 4 kidney disease.
The EPICK study, designed to demonstrate that PhosLo is effective and safe in controlling hyperphosphatemia in Stage 4 CKD patients without causing very low calcium levels (hypocalcemia), or high levels of acidity in the blood (metabolic acidosis), achieved its primary endpoint of superior serum phosphorus control versus placebo with a P-value equal to 0.0003.
The secondary endpoints of the study were also achieved by demonstrating that attaining a parathyroid level (PTH) target of 70 - 110 pg/mL is more likely with PhosLo than with placebo and by showing that attaining a calcium phosphorus product (CA x P) of 23 - 43 mg2/dL2 is more likely with PhosLo than with placebo.
PhosLo is a prescription phosphate binder currently indicated for the control of elevated phosphorous levels (hyperphosphatemia) in patients with end-stage renal (kidney) disease (ESRD). If clinical studies aand drug regulations approvals are met, PhosLo would be the only phosphate binder on the
The study findings were presented as poster on October 13, 2006 at the International Society of Nephrology (ISN) Symposium in
Find more deatils from the press release.
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