Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Intervention: LCP-Tacro; Prograf
Intervention description: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.; Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.
Intervention MeSH terms: Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: kidney transplantation; renal transplantation; maintenance immunosuppression; tacrolimus; Prevention of acute allograft rejection

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women at least 18 years of age who are recipients of a kidney transplant
             between 3 months and 5 years before the screening date

          -  Patients taking oral Prograf® capsules twice daily, at least 2 mg total dose per day,
             as part of their maintenance immunosuppression therapy, with tacrolimus trough levels
             of 5 to 15 ng/mL

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             within 7 days before receiving study drug

        Exclusion Criteria:

          -  Recipients of any transplanted organ other than kidney

          -  Recipients of a bone marrow transplant

          -  Patients with an eGFR (MDRD7) < 30 mL/min at Screening

          -  Patients with a spot protein:creatinine ratio > 0.5

          -  Patients with a WBC count ≤ 2.8 ´ 109/L unless the WBC count has been stable for at
             least 2 weeks and the absolute neutrophil count is > 1.0 ´ 109 /L

          -  Patients unable to swallow study medication

          -  Patients incapable of understanding the purposes and risks of the study, who cannot
             give written informed consent and who are unwilling or unable to comply with the study
             protocol requirements

          -  Pregnant or nursing women

          -  Patients with reproductive potential who are unwilling/unable to use a double barrier
             method of contraception

          -  Patients who were treated with any other investigational agent within 3 months before
             Screening

          -  Patients who have taken sirolimus or everolimus within 3 months before Screening

          -  Patients on concurrent immunosuppression with MMF (CellCept) or MPS delayed-release
             tablets (Myfortic) who have not been on stable doses for at least 4 weeks before
             Screening

          -  Patients withdrawn from corticosteroids less than 30 days before Screening

          -  Patients with an episode of acute rejection requiring antibody therapy within 3 months
             before Screening

          -  Patients treated for acute rejection within 30 days before Screening

          -  Patients who are hepatitis C virus (HCV) negative who have received an HCV positive
             (HCV RNA by polymerase chain reaction or HCV antibody) donor kidney

          -  Patients seropositive for human immunodeficiency virus

          -  Patients with a current malignancy or a history of malignancy (within the past 5
             years), except basal or nonmetastatic squamous cell carcinoma of the skin that has
             been treated successfully

          -  Patients with uncontrolled concomitant infection, a systemic infection requiring
             treatment, or any other unstable medical condition that could interfere with the study
             objectives

          -  Patients with severe diarrhea, vomiting, active peptic ulcer, or gastrointestinal
             disorder that may affect the absorption of tacrolimus

          -  Patients with any form of current substance abuse, psychiatric disorder, or a
             condition that, in the opinion of the investigator, may invalidate communication with
             the investigator.