Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients
Condition: Renal Transplantation
Intervention: Everolimus; Cyclosporine; Enteric-coated mycophenolate sodium; Corticosteroids
Intervention description: Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL.; Tablets orally twice a day to maintain protocol specific target blood levels; Enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day.; Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Renal transplantation, everolimus, immunosuppressants, CNI-free

Summary:

      The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen
      with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and
      well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium
      (EC-MPS) and cyclosporine microemulsion, but results in better renal function.
    

Eligibility criteria:

        Inclusion Criteria :

        The following inclusion criteria had to be present at BL 1 (Screening visit prior to
        transplantation):

          1. Males or females, aged 18 - 65 years

          2. Recipients of de novo cadaveric, living unrelated or living related kidney transplants

          3. Females capable of becoming pregnant must have a negative serum pregnancy test within
             7 days prior to or at BL 1, and are required to practice an approved method of birth
             control for the duration of the study and for a period of 6 weeks following
             discontinuation of study medication, even where there has been a history of
             infertility

          4. Patients who are willing and able to participate in the study and from whom written
             informed consent has been obtained

             Of all patients included into the study at BL 1 (prior to transplantation), those who
             continued into the randomized study period had to meet the following condition at BL
             2, prior to randomization:

          5. Patients had to be on an immunosuppressive regimen with EC-MPS (target dose; 1440
             mg/day, if tolerated; minimal dose: 720 mg/day), cyclosporine and corticosteroids

          6. Patients with an actual serum creatinine =< 3.0 mg/dl

        Exclusion Criteria:

        The following exclusion criteria must not be present at BL 1 (Screening visit prior to
        transplantation):

          1. More than one previous renal transplantation

          2. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any
             other organ, different from kidney

          3. Graft loss due to immunological reasons in the first year after transplantation (in
             case of secondary transplantation)

          4. Patients who are recipients of A-B-O incompatible transplants

          5. Patients with a historical or current peak PRA of > 25%

          6. Patients with already existing antibodies against the HLA-type of the receiving
             transplant

          7. Females of childbearing potential who are planning to become pregnant, who are
             pregnant and/or lactating, who are unwilling to use effective means of contraception

             Of all patients included into the study at BL 1 (prior to transplantation), those who
             met one or more of the following criteria at BL 2, prior to randomization, should not
             continue into the randomized study period:

          8. Graft loss or death

          9. Changes to the immunosuppressive regimen prior to randomization due to immunologic
             reasons

         10. Patients who suffered from severe rejection (>= BANFF II acute rejection), recurrent
             acute rejection, or steroid resistant acute rejection

         11. Proteinuria > 1g/day

        Other protocol-defined exclusion criteria may apply.