Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Intervention: Prograf (tacrolimus); LCP-Tacro
Intervention description: Administered per current product labeling; Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
Intervention MeSH terms: Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 543.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Tacrolimus; Acute Rejection; Kidney

Summary:

      This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets
      administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as
      immunosuppression for the prevention of organ rejection in newly transplanted adult kidney
      transplant recipients. Patients will be treated for a 12 month study period followed by a 12
      month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically
      similar to Prograf Capsules in the prevention of acute rejection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. informed consent

          2. 18 and 70 years, inclusive

          3. receiving primary or secondary renal allograft from a deceased donor or non-human
             leukocyte antigen (HLA) identical living donor

          4. no known contraindications to the administration of IL-2 receptor antagonist induction
             therapy, MMF, corticosteroids or tacrolimus

          5. negative pregnancy test

          6. Negative cross match test, and compatible (A, B, AB or O) blood type

          7. Able to swallow tablets and capsules

        Exclusion Criteria:

          1. Recipients of any non-renal transplant (solid organ or bone marrow) ever

          2. Panel reactive antibody (PRA) >30%

          3. Patients with any condition that may affect study drug absorption (e.g. gastrectomy or
             clinically significant diabetic gastroenteropathy)

          4. Body mass index (BMI) 18 kg/m2

          5. History of alcohol abuse

          6. History of recreational drug abuse

          7. Screening 12-lead electrocardiogram (ECG) demonstrating clinically relevant
             abnormalities

          8. WOCBP who are either pregnant, lactating, planning to become pregnant

          9. Patients with an oral temperature (prior to study drug dosing) of 38.0 ºC (100.4 ºF)
             or higher

         10. Patients with clinically significant active infections

         11. Patients with a known hereditary immunodeficiency

         12. Patients with malignancies or with a history of malignancies (within the last 5 years)

         13. Patients who are receiving or expect to receive sirolimus, everolimus, azathioprine,or
             cyclophosphamide within 3 months prior to enrollment

         14. Patients with evidence of clinically significant disease (e.g., cardiac,
             gastrointestinal or hepatic disorders)

         15. Patients with reversible cardiac ischemia (history of untreated reversible ischemia on
             stress test)

         16. Patients with clinically symptomatic congestive heart failure or documented ejection
             fraction of less than 45%

         17. Patients with significant chronic obstructive pulmonary disease, pulmonary restrictive
             disease or significant pulmonary hypertension

         18. Treatment with an investigational drug, device or regimen within 1 year preceding the
             first dose of study drug

         19. Patients who are unwilling to refrain from consumption of grapefruit or grapefruit
             containing juices

         20. Patients receiving concomitant drugs that may affect concentrations of tacrolimus in
             whole blood, as listed in Appendix 2

         21. Laboratory variables that are abnormal (outside laboratory reference range) and
             clinically relevant, as judged by the Investigator

         22. Patients with positive results of any of the following serological tests: human
             immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen
             (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus
             (HCV)antibody (HCV Ab).

         23. Patients who experienced graft loss within 1 year of transplant, due to acute
             rejection or due to BK nephropathy

         24. Patients having experienced focal segmental glomerulosclerosis (FSGS)

         25. Donor with positive serological test result for HIV-1, HBV or HCV

         26. Donor with history of malignant disease (current or historical)

         27. Centers for Disease Control and Prevention high-risk donor

         28. Patients with mental dysfunction or inability to cooperate with the study

         29. Cold ischemia time >30 hours

        29. Non-heart-beating donor