Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3
controlled trial to establish the efficacy and safety of conversion from maintenance
immunosuppressive therapy with Prograf® capsules (tacrolimus, Astellas Pharma US, Inc.,
Deerfield, IL) twice daily to maintenance immunotherapy with LCP Tacro™ tablets (tacrolimus,
LifeCycle Pharma A/S, Hoersholm, Denmark) once daily for the prevention of acute allograft
rejection in stable adult kidney transplant patients. Patients on a stable dose of Prograf®
will be randomly assigned to be converted from Prograf® twice daily to LCP Tacro™ once daily
or to remain on maintenance therapy with Prograf® twice daily. Patients entering the study
will be treated with assigned study drug and followed for one year for patient survival and
the incidence of graft rejection or graft loss.