Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)
Condition: Kidney Transplant; Diabetes Mellitus, Type 2; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Cyclosporin; Tacrolimus; 'Diabetes Education / Management'
Intervention description: Dose adjustment to pre-established targets; Dose adjustment to pre-established targets; therapeutic adjustment to target ADA criteria
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: kidney Transplant; Type II Diabetes; Diabetic Nephropathy; Immunosuppression; Cyclosporin; Tacrolimus

Summary:

      Protocol Title: Randomized open label study comparing the metabolic control of first Kidney
      Transplant recipients with Type 2 Diabetes Mellitus (DM) receiving either Prograf or Neoral
      as part of a ATG induction, prednisone free and blood monitored Cellcept immunosuppressive
      regimen.

      PURPOSE This is a single center medical research study to analyze post-transplant kidney
      recipients with pre-existing type 2 diabetes managed according to the recommended American
      Diabetes Association (ADA) guidelines. Prograf (Tac) and Neoral (CSA) are the two main
      medications to prevent rejection after transplantation. However, they may contribute to
      poorer diabetes control. The purpose of the study is to compare the effects of Prograf and
      Neoral on the control of Diabetes after kidney transplantation. In addition, all participants
      in this study will receive Thymoglobulin (anti-lymphocyte globulin) at the time of
      transplantation instead of long term prednisone (steroids).
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria

          1. Patient is a recipient of a first cadaveric kidney, or a kidney living donor
             mismatched (at least one mismatch.)

          2. Patient is a minimum of 18 years of age at the time of transplant.

          3. Patient has type 2 non-insulin dependent diabetes.

          4. Patient or legal guardian has signed and dated an Ethics Committee-approved informed
             consent document and is willing and able to follow study procedures.

          5. If female and is childbearing potential, patient has a negative pregnancy test and
             utilizes adequate contraceptive methods.

        Exclusion Criteria

          1. Recipients of a transplant graft from a donor age 65 and older.

          2. Recipient of a multi-organ transplant.

          3. Patients who are being re-transplanted will not be eligible for study.

          4. Patients who have lost a previous graft to rejection less than one year from
             transplant.

          5. Patient has any form of substance abuse, psychiatric disorder, or a condition in the
             opinion of the investigator, may invalidate communication with the investigator.

          6. PRA > 30%