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news.Veloxis Pharmaceuticals has completed enrolment in its pivotal LCP-Tacro 3002 Phase III study in de novo kidney transplant patients.
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The study is designed to demonstrate non-inferiority versus the gold standard therapy Prograf and has randomized over 540 patients at approximately 90 sites around the world.
The randomized, double-blind, multi-centre study will compare once-daily LCP-Tacro against twice-daily Prograf in de novo adult kidney transplant patients.
The primary endpoint of the study is a composite endpoint, Biopsy Proven Acute Rejection, graft failure, loss to follow up or death and secondary endpoints include safety, tolerability and renal function assessments.
Veloxis CEO and president Bill Polvino said with the results of 3001 study already complete and 3002 study fully enrolled, the company has completed enrolment in its LCP-Tacro Phase 3 registration trials.
"This puts Veloxis firmly on track for submission of a New Drug Application (NDA) next year," Polvino added.