Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.
Condition: Renal Transplantation
Intervention: Everolimus; Cyclosporin A (CsA); Tacrolimus; Enteric Coated - Mycophenolate Sodium (EC-MPS); Corticosteroids
Intervention description: Participants, switching from the CsA based treatment, initially received everolimus 1.5 mg/day and then from day 7, 3 mg/day, and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). Participants, switching from the tacrolimus based treatment, initially received 3 mg/day and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml).; The dose was based on the participants' blood level of C0h (80-150 ng/ml).; The dose was based on the participants' blood level of C0h (5-10 ng/ml).; The dose was ≥ 720 mg/day.; Corticosteroids were given according to local standard and/or the Investigators' discretion.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Tacrolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: enteric-coated mycophenolate sodium, everolimus, CNI-free regimen

Summary:

      Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant
      recipients to prevent graft rejection, may cause renal impairment. The aim of this study is
      to assess whether a CNI-free regimen with enteric-coated mycophenolate sodium and everolimus
      is as safe and well tolerated as a standard regimen consisting of enteric-coated
      mycophenolate sodium and cyclosporine microemulsion without a compromise in therapeutic
      efficacy while resulting in an improved renal function.
    

Eligibility criteria:

        Inclusion Criteria:

        Males or females, aged > 18 years, Maintenance renal transplant recipients at least 6
        months post-transplantation, Patients with a serum creatinine < 2,5 mg/dL stable for at
        least three month (according to the investigator), Females capable of becoming pregnant had
        to have a negative serum pregnancy test within seven days prior to or at baseline, and were
        required to practice an approved method of birth control for the duration of the study and
        for a period of six weeks following discontinuation of study medication, even where there
        had been a history of infertility, Patients receiving Myfortic® (Myfortic dose . 720 mg/d)
        and Sandimmun® Optoral with or without corticosteroids as part of their immunosuppressive
        regimen for at least 1 month before baseline;

        Exclusion Criteria:

        More than one previous renal transplantation, Multi-organ recipients (e.g., kidney and
        pancreas) or previous transplant with any other organ, different from kidney, Patient with
        proteinuria > 1000 mg/day at baseline, Hypersensitivity to Certican®, Sandimmun® Optoral,
        Prograf®, mycophenolic acid, or other components of the formulation, Patients who had
        received an investigational drug within four weeks prior to baseline, Severe rejection (≥
        Banff II acute rejection), recurrent acute rejection, or steroid resistant rejection within
        six months of enrollment, Thrombocytopenia (platelets < 100,000/mm³), with an absolute
        neutrophil count of < 1,500/mm³ or leukopenia (leukocytes < 4,000/mm³), or hemoglobin < 8
        g/dL, Abnormal physical or laboratory findings of clinical significance within two weeks of
        study inclusion which at the investigator's discretion would interfere with the objectives
        of the study, Symptoms of significant somatic or mental illness. Inability to cooperate or
        communicate with the investigator, or patients who were unlikely to comply with the study
        requirements, or who were unable to give informed consent, History of malignancy during the
        last five years, except squamous or basal cell carcinoma of the skin, Patients who were HIV
        positive, or hepatitis C, or hepatitis B surface antigen positiveEvidence of severe liver
        disease (including abnormal liver enzyme profile, i.e. aspartate transaminase (AST),
        alanine aminotransferase (ALT) or total bilirubin > 3 times upper limit of normal (ULN),
        Females of childbearing potential who were planning to become pregnant, who were pregnant
        or lactating and/or who were unwilling to use effective means of contraception, Presence of
        a clinically significant infection requiring continued therapy, severe diarrhea, active
        peptic ulcer disease or uncontrolled diabetes mellitus that in the opinion of the
        investigator would interfere with the appropriate conduct of the study, Evidence of drug or
        alcohol abuse

        Other protocol-defined exclusion criteria may apply.