Veloxis Pharmaceuticals announced results from its LCP-Tacro Phase 3 clinical trial in stable kidney transplant patients, the 3001 study. LCP‐Tacro is an investigational drug that it is being developed as a once‐daily tablet version of tacrolimus. Tacrolimus is an immunosuppressant used for the prevention of transplant allograft rejection after organ transplantation.
The study was a randomized, controlled, multicenter trial, which demonstrated that LCP-Tacro dosed once-daily was not inferior to Prograf (tacrolimus; Astellas Pharma), dosed twice-daily. Non-inferiority was determined by a composite endpoint, measured over a year of follow up that included death, graft failure, biopsy-proven acute rejection or loss to follow-up. Results of this trial demonstrated that patients can be converted from twice-daily Prograf to once-daily LCP-Tacro. The results also demonstrated that, over the 12 month study, the daily dose of LCP-Tacro could be lowered compared to the baseline Prograf dose, while the target blood levels remained stable and within target range.
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