Trials & Filings

Rapamune Misses Renal Function Endpoint

Pfizer transplant drug shows no improvement over tacrolimus-based therapy

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Pfizer has posted top-line results from a Phase IIIb/IV study of Rapamune (sirolimus) evaluating kidney transplant patients who transitioned from tacrolimus-based therapy (TAC) to Rapamune three to five months after transplant. The primary endpoint of the study was not achieved as there was not a statistically significant difference in renal function improvement between patients who continued receiving TAC and those who switched to Rapamune. For patients who were switched to Rapamune, 33.7% of ...

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