A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients
Condition: Renal Transplantation
Intervention: Everolimus (RAD001); Tacrolimus; Basiliximab; Corticosteroids
Intervention MeSH terms: Everolimus; Tacrolimus; Basiliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate whether tacrolimus dose reduction in de novo renal
      recipients receiving everolimus can preserve renal function while maintaining efficacy.
    

Eligibility criteria:

        Inclusion criteria

          -  Male or female of 18-65 years old

          -  Patient who has received a primary kidney transplant from a cadaveric, living
             unrelated or non-human leucocyte antigen (HLA) identical living related donor

          -  Recipient of a kidney with a cold ischemia time (CIT) < 30 hours

          -  Recipient of a kidney from a donor 10-65 years old

          -  Patient able to receive the first dose of tacrolimus within 24 hours from graft
             reperfusion

          -  Female capable of becoming pregnant must have a negative pregnancy test and is
             required to practice a medically approved method of birth control for the duration of
             the study and for a period of three months following discontinuation of
             investigational drug

          -  Patient willing and capable of giving written informed consent for study participation
             and able to participate in the study for 12 months

        Exclusion criteria

          -  Patient who has previously received an organ transplant

          -  Recipient of multiple organ transplants

          -  Recipient of a kidney transplant from a non heart-beating donor

          -  Recipient of donor specific transfusions

          -  Recipient of A-B-O incompatible transplant or T-cell cross-match positive transplant

          -  Patient with current Panel Reactive Antibodies (PRA) level ≥ 50%

          -  Recipient of a kidney from a donor who tests positive for hepatitis B surface antigen
             or hepatitis C antibodies

          -  Patient who is human immunodeficiency virus (HIV) positive

          -  Patient who has a positive hepatitis C serology or who is hepatitis B surface antigen
             positive with evidence of liver injury as indicated by aspartate aminotransferase
             (AST)/alanine aminotransferase (ALT) levels ≥2.5 times upper limit of normal (UNL).
             Viral serology results obtained within 6 months prior to the administration of the
             first dose of Certican™ are acceptable

          -  Patient with severe hypercholesterolemia (350 mg/dL, 9.1 mmoL/dL) or
             hypertriglyceridemia ( 500 mg/dL, 5.6 mmoL/L)

          -  Patient with white blood cell (WBC) count 3,000/mm3 or with platelet count 75,000/mm3

          -  Patient with any severe allergy requiring acute (within 4 weeks of baseline) or
             chronic treatment, or with hypersensitivity to drugs similar to Certican (e.g.,
             macrolides)

          -  Patient who has been treated with an immunosuppressive drug or an investigational drug
             within 4 weeks prior to the administration of the first dose of Certican

          -  Patient with uncontrolled infection

          -  Patient with any surgical or medical condition, other than the current transplant,
             which in the opinion of the investigator, precludes enrollment in this trial

          -  Patient with a known malignancy or a history of malignancy within last 5 years other
             than successfully treated localized basal or squamous cell carcinoma of the skin

          -  Abnormal physical or laboratory findings of clinical significance within 2 weeks prior
             to the administration of the first dose of Certican™ which at investigator's
             discretion would interfere with the objectives of the study

          -  Breast feeding women

          -  Patient with symptoms of significant somatic or mental illness or with unresolved
             history of drug or alcohol abuse

          -  Patient unable to cooperate or communicate with the investigator