Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation
Condition: Diabetes Mellitus, Adult-Onset
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tacrolimus with rapid steroid withdrawal; Tacrolimus with steroids minimization; CsA with steroid minimization
Intervention description: Basiliximab induction (4 mg i.v., days 0 and 4).
Corticosteroids: 0.5 gr of i.v. Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7.
Tacrolimus: 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml.
Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d.; Basiliximab induction (4 mg i.v., days 0 an 4)
Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months.
Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml.
Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d.; Basiliximab induction (4 mg i.v., days 0 an 4)
Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months.
CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month and then 100-150 ng/ml.
Mycophenolate mofetil 1 gr b.i.d
Intervention MeSH terms: Mycophenolic Acid; Cyclosporine; Prednisone; Tacrolimus; Basiliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      New onset diabetes after renal transplantation (NODAT) is a common and severe complication
      negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the
      basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection
      and graft function. However, Tacrolimus increases 2 times the risk of NODAT as compared to
      CsA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary renal transplant recipients with end stage renal disease

          -  No prior history of diabetes mellitus before transplant

          -  Absence of Immunologic risk defined by the investigator criterion and Panel Reactive
             Antibody (PRA) < 50%

          -  Absence of severe infection and hepatitis C or B infection

          -  Efficient contraception in women during the study

        Additionally must meet one of these "Metabolic Criteria

          -  Recipient age >or =60 or

          -  Recipient age between 45 and 59 years and at least one of the following metabolic
             criteria: Prior to transplantation Triglycerides (TGS) >200mg/dl or the combination of
             a body mass index (BMI)> 27 and Triglycerides>150 mg/dl or the combination of
             HDL-cholesterol<40 mg/dl for men or <50 mg/dl for women and Triglycerides >150 mg/dl.

        Exclusion Criteria:

          -  Patients with type I or II diabetes prior to transplantation defined by the American
             Diabetes Association (ADA) criteria

          -  Recipient age under 45

          -  Patients receiving a second renal transplant

          -  Patients with high immunological risk or PRA (panel reactive antibody level) >or =50%

          -  Severe infection or hepatitis C or B infection.

          -  Dual renal transplant or double transplant with any other organ.