Wednesday, October 10, 2012

EPPIC Study - AST-120 ( Kremezin) fails to demonstrate statistically significant efficacy over standard of care in Chronic Kidney Disease (CKD) patients

The EPPIC study enrolled approximately 2000 moderate to severe Chronic Kidney Disease patients in the US and Europe.  The primary endpoint of the study was time to initiation of dialysis, kidney transplantation or doubling of serum creatinine. 

Although statistically significant benefit was not observed in the overall population, but a subgroup analysis suggested that Kremezin (AST-120) was effective in patients with fast progressive chronic kidney disease.

AST-120 was studies at a dose of 9 g/day as against 6 g/day which is already approved in Japa. AST-120 is marketed under the brand name Kremezin in Japan since 1991. Kremezin in an oral adsorbent consisting of highly purified spherical carbon. It adsorbs uremic toxins relesed in the GI tract and is eliminated in the feces.

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