The Phase III randomized, double-blind and double-dummy study in 543 de novo kidney transplant recipients, with Prograf as the comparator, met its primary efficacy and primary safety endpoints.
The study was conducted under a Special Protocol Agreement with the FDA and the results are considered pivotal for the planned U.S. regulatory filing expected to occur in the second half of 2013.
"The results observed in this clinical trial suggest that new kidney transplant patients can begin with a regimen of once-daily LCP-Tacro™ rather than twice-daily as required with current tacrolimus products, without compromising efficacy and tolerability," said Dr. Suphamai Bunnapradist, M.D., Professor of Medicine and Director of Kidney Transplant Research at the Ronald Reagan Medical Center and David Geffen School of Medicine at UCLA, California, USA. "This is important because once-daily dosing should be beneficial for kidney transplant patients who are on life-long complex therapy."
LCP-Tacro demonstrated non-inferiority to Prograf in preventing kidney transplant rejection, including in the early post-transplant period
The primary endpoint of the study was a composite endpoint of treatment failure (biopsy-proven acute rejection or BPAR, graft failure, loss to follow up or death) that was evaluated after a 12-month treatment period to demonstrate the non-inferiority of LCP-Tacro compared to Prograf.
The treatment failure rate for LCP-Tacro was 18.3% compared to 19.6% for Prograf, well within the 10% pre-specified non-inferiority margin.