12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
Condition: Kidney Transplantation; Renal Transplantation
Intervention: Everolimus; Tacrolimus; Cyclosporin A; Enteric Coated Mycophenolate Sodium (EC-MPS); Mycophenolate mofetil (MMF); Corticosteroids; Simulect
Intervention description: Capsules: 0.5 mg, 1 mg or 5 mg. Dosing schedule: transplant to month 2: 4-8ng/ml, month 3 to month 12 3-5 ng/ml according to standard blood levels; Capsules: 10 mg, 25 mg, 50 mg or 100 mg. Transplantation to month 2: 75 - 125 ng/ml, month 3 to month 12: 50 - 100 ng/ml; Tablets: 180 mg or 360 mg. Dosing: duration of study 360 mg bid and no less than 360 mg daily dose; Capsules: 250 or 500 mg. Dosing: duration of study 500 mg bid and no less than 500 mg total daily dose; A minimum dose of 5 mg prednisolon or equivalent; Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Tacrolimus; Cyclosporins; Basiliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 612.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Transplant; Renal transplant; Rejection,allograf; Rejection; Xenograft rejection; Host vs graft disease; Kidney Transplant

Summary:

      This study was designed to evaluate the renal function comparing Certican based
      immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a
      standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant
      recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient who had received a primary or secondary kidney transplant

          -  Patients who were willing and from whom written informed consent was obtained

          -  kidney allograft with a cold ischemia time (CIT) < 30 hours

          -  negative pregnancy test prior to study enrollment

        Exclusion Criteria:

        --Multi-organ recipients

          -  former Graft loss due to immunological reasons

          -  Patients who received a kidney from a non-heart beating donor

          -  A-B-0 incompatible transplants

          -  a current Panel Reactive Antibody (PRA) level of > 20%

          -  existing antibodies against the HLA-type of the receiving transplant

          -  a known hypersensitivity/contraindication to any of the immunosuppressants

          -  Use of other investigational drugs

          -  Patients with thrombocytopenia (platelets < 100,000/mm³), with an absolute neutrophil
             count of < 2,000/mm³ or leucopenia (leucocytes < 3,000/mm³), or hemoglobin < 8 g/dL

          -  significant mental illness

          -  history of malignancy during the last five years

          -  HIV positive

          -  uncontrolled hypercholesterolemia or hypertriglyceridemia

          -  drug or alcohol abuse

          -  pregnant or breast feeding women