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Date: 2009-12-23
Phase: III
Anouncement: Launch
Biotech: LifeCycle Pharma (Denmark)
Pharma:
Product: LCP-Tacro® (once-daily tablet version of tacrolimus)
Disease: de novo kidney transplant recipients
Country: USA and Europe
Other: LifeCycle Pharma has submitted the phase 3 protocol for LCP-Tacro™ in de novo kidney transplant recipients to the FDA. LCP will review the protocol with the Agency and expects thatenrollment of patients will begin near the middle of 2010.
The upcoming Phase 3 study in de novo kidney transplant patients will run in parallel with LCP's current ongoing Phase 3 study in stable kidney transplant patients (See clinical_studies).
This trial is planned as a multi-center, prospective, parallel group study in de novo kidney transplant patients. De novo kidney transplant candidates are planned to be randomized to receive either LCP-Tacro™ or Prograf® following their kidney transplantation. As per regulatory requirements, a traditional composite endpoint consisting of death, graft failure, biopsy-proven acute rejection or loss to follow up at 12 months after randomization will be the primary efficacy outcome.

- On August 12, 2010, Life Cycle Pharma announced receipt of agreement with the FDA on a Special Protocol Assessment (SPA) of its pivotal Phase 3 study, Study 3002, for LCP-Tacro® in patients, who have just received a kidney transplant (“de novo” transplant patients).

The LCP Study 3002 is a randomized, double-blind, multicenter study that will compare once-daily LCP-Tacro® against the current market leading comparator, twice-daily Prograf® in de novo kidney transplant patients. A 12-month treatment period will be followed by a 12-month blinded extension. The primary endpoint of the study will be to demonstrate the non-inferiority of LCP-Tacro® compared to Prograf®, on kidney graft function (biopsy proven acute rejection,
graft failure, death, or loss to follow up) at 12 months.
Secondary endpoints will include safety, tolerability and renal function assessments. The study will be conducted at approximately 75-100 transplant centers, primarily in USA and Europe.