Optima: Optimizing Prograf Therapy in Maintenance Allografts II
Condition: Kidney Transplantation
Intervention: cyclosporine; Prograf (Tacrolimus)
Intervention description: Maintain on cyclosporine at target trough level of 50-250 ng/mL.; Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).
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: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Kidney Transplantation; Immunosuppressive Agents

Summary:

      This study is designed to optimize calcineurin immunosuppressive regimens and evaluate
      immunological and non-immunological markers that may explain mechanistic differences in these
      agents and their effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is the recipient of a cadervic or living donor renal transplant.

          -  Patient was 18 years of age at time of transplant.

          -  Patient is at least 6 months post-transplant.

          -  Patient has been on a cyclosporine-based immunosuppressive regimen since the
             transplant.

          -  Patient has a functioning allograft and a Cockcroft/Gault estimate of creatinine
             clearance >or= 35 mL/min within four weeks prior to randomization.

          -  Patient or legal guardian has signed and dated an Institutional Review Board (IRB)
             approved informed consent document and is willing and able to follow study procedures.

          -  Females are not pregnant and agree to practice effective birth control while receiving
             immunosuppressant medication.

        Exclusion Criteria:

          -  Patient is the recipient of a solid organ transplant other than the kidney.

          -  Patient experienced biopsy-confirmed, acute rejection, (Banff 97 criteria)within 3
             months before randomization that required treatment, which is defined as
             antilymphocyte therapy, corticosteroids, or an increase in the number or dose of
             immunosuppressant medication.

          -  Patient has recurrence of primary renal disease, or de novo renal disease.

          -  Patient has a urine protein of > 1.5g/24 hours or two successive urinalyses sent to
             and reported by the laboratory indicating albuminuria greater than 2+ within 6 months
             prior to enrollment.

          -  Patient has an estimated creatinine clearance < 35 mL/min calculated using
             Cockcroft/Gault formula within four weeks prior to randomization.

          -  Patient has changed adjunctive immunosuppressant therapy within one month if
             randomization.

          -  Patient is pregnant or lactating.

          -  Patient is a known carrier of any of the HIV viruses.

          -  Patient has a known or suspected malignancy (except for treated squamous or basal cell
             skin cancers) < 5 years before randomization or a history of post-transplant
             lymphoproliferative disease (PTLD).

          -  Patient has a known hypersensitivity to tacrolimus, or any of the excipients of the
             drug.