Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study)
Condition: Renal Transplantation
Intervention: Simulect®; Neoral®; Certican®; Myfortic®; Corticosteroids
Intervention description: Simulect® was provided to the study center in its commercial package containing a powder vial with 20 mg of active product and sterile water for injection. The solution should be used immediately after reconstitution. The infusion was prepared by adding at least 50 mL of physiologic or 5% glucose solution to the reconstituted solution (at least 100 mL for 40 mg of Simulect®). Simulect® was transported and kept in a cold environment (2-8°C) as recommended in the summary of product characteristics (SPC).; Neoral® was provided to the study center in its commercial package as 10, 25, 50 or 100 mg soft capsules in thermoformed blister packs.; Certican® was provided to the study center in its commercial package as 0.75, 0.5 and 0.25 mg tablets in thermoformed blister packs.; Myfortic® was administered orally b.i.d. with a 12-hour interval. Tablets could be taken either with or outside meals but consistently throughout the study. To maintain the integrity of the enteric coating, tablets were not to be crushed. Myfortic® treatment was initiated either preoperatively or within 24 hours post transplantation according to local practice in each center. Starting dose was to be 2160 mg/day (1080 mg b.i.d.) for at least 2 weeks and for at most 4 weeks. Patients were then to receive 1440 mg/day (720 mg b.i.d.) until the end of the study. Myfortic® was administered as concomitant treatment to all patients, using the same regimen for all 3 study groups. It was provided to the study center in its commercial package as 180 and 360 mg gastro-resistant tablets.; Corticosteroid i.v. therapy could be administered peri or per operatively according to local practice in each center with the same scheme for each patient in the center. Oral corticotherapy was to be initiated rapidly, within one week following transplantation, with a minimal dose of 20 mg/day. Thereafter, the dose was to be decreased according to local practice but oral corticosteroids were to be continued throughout the study with a minimal dose of 5 mg/day.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins; Basiliximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Basiliximab; renal transplantation; CNI-free; everolimus

Summary:

      The aims of this study are to extensively study the levels of CD25-Receptors saturation and
      expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to
      demonstrate that saturation and expression vary according to the dose of Simulect® given),
      and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the
      data with Neoral®.

      It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks
      post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in
      combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin
      inhibitor free immunosuppressant therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients receiving a primary renal graft from a deceased or living, related or
             unrelated donor and who require basiliximab induction therapy

          -  Cold ischemia time < 30 hours

        Exclusion (Non inclusion) criteria:

          -  Patients undergoing multi-organ transplantation, including both kidneys, or who have
             previously undergone organ transplantation, including renal transplantation

          -  Patients receiving a graft from a non-heart-beating donor

          -  A-B-O incompatible graft or positive T cell crossmatch

          -  Patients receiving a graft from an expanded criteria donor according to the UNOS
             definition (donor older than 60 years or donor aged between 50 and 60 years and
             presence of at least 2 of the following factors: hypertension, serum creatinine
             concentration ≥ 132 µmol/mL, cardiovascular cause of death)

          -  Positive anti-HLA antibodies (Luminex) prior to transplantation

          -  Patients whose original renal disease was primary focal and segmental hyalinosis or
             was related to atypical hemolytic uremic syndrome

          -  EBV-negative patients receiving a graft from an EBV-positive donor (EBV D+R-)

        Other protocol-defined inclusion/exclusion criteria may apply.